Methods and systems for delivering prostheses using rail techniques

ABSTRACT

Exemplary embodiments provide methods and systems for delivering a prosthesis to a target location in a lumenal system of a patient. At least one tether is secured proximate the target location to serve as a rail, and a prosthesis is advanced along the rail to the target location and secured in place. Exemplary methods and systems provide for repair of the mitral and tricuspid valves, as well as abdominal aortic aneurysms, stomach valves, fallopian tubes and the pulmonary system, among others. Also disclosed are various prostheses suitable for use with the disclosed methods and systems.

RELATED APPLICATIONS

This application is a continuation-in-part of and claims the benefit ofInternational Application No. PCT/US2011/059586, filed Nov. 7, 2011,which in turn claims the benefit of priority to U.S. patent applicationSer. No. 13/240,793, filed Sep. 22, 2011, U.S. Provisional PatentApplication Ser. No. 61/410,877, filed Nov. 6, 2010, U.S. ProvisionalPatent Application Ser. No. 61/451,899, filed Mar. 11, 2011 and U.S.Provisional Patent Application Ser. No. 61/431,384, filed Jan. 10, 2011.This application is also related to U.S. Provisional Patent ApplicationNo. 61/385,843, filed Sep. 23, 2010, U.S. Provisional Patent ApplicationNo. 61/245,246, U.S. Provisional Patent Application No. 61/310,783 andU.S. Provisional Patent Application No. 61/354,298. The entire contentsof each of the above-referenced applications are incorporated herein byreference in their entirety for any purpose whatsoever.

BACKGROUND

Valvular heart diseases include mitral valve prolapse in which a leafletof the mitral valve is displaced into the left atrium during thesystolic phase of a cardiac cycle. Mitral valve prolapse can lead tomitral regurgitation in which the mitral valve does not close properlyduring the systolic phase, causing abnormal leaking of blood from theleft ventricle, through the mitral valve and into the left atrium.

Valvular heart diseases also include mitral stenosis in which theorifice of the mitral valve is abnormally narrowed, thus impeding bloodflow into the left ventricle. Similarly, tricuspid stenosis can impedeblood flow into the right ventricle. Some patients may be affected by acombination of mitral/tricuspid stenosis and mitral/tricuspid valveregurgitation, while others may be affected by either one or the other.Serious valvular heart diseases may be treated by replacing or repairingthe defective heart valve in an open heart surgical procedure in which apatient's defective heart valve is manually or robotically replaced witha different valve. The open heart surgical replacement procedurerequires placing the patient on cardiopulmonary bypass to stop bloodflow through the heart when the heart is opened up.

SUMMARY

In accordance with one exemplary embodiment, a valve prosthesis isprovided. The valve prosthesis may include a tubular member configuredfor deployment in a heart valve annulus, a first set of fasteningmechanisms radially and outwardly disposed from the tubular member andconfigured to attach the valve prosthesis to cardiac tissue above theheart valve annulus, and a second set of fastening mechanisms radiallyand outwardly disposed from the tubular member and configured to attachthe valve prosthesis to cardiac tissue below the heart valve annulus.The valve prosthesis may also include a third set of fasteningmechanisms radially and outwardly disposed from the tubular member andconfigured to attach the valve prosthesis to cardiac tissue at or abovethe heart valve annulus.

The first set of fastening mechanisms may be formed by proximal portionsof a series of loop elements that are connected to form a loopedstructure. The second set of fastening mechanisms may be formed bydistal portions of a series of loop elements that are connected to forma looped structure.

The valve prosthesis may include a plurality of first loop elementsconnected to form a ring shape. Each of the first loop elements mayinclude a mid portion, a proximal portion that extends radially andoutwardly away from the mid portion at a first terminal end of the midportion, and a distal portion that extends radially and outwardly awayfrom the mid portion at a second terminal end of the mid portion. Themid portions of the plurality of first loop elements may form thetubular member of the valve prosthesis. The proximal portions of theplurality of first loop elements may form the first set of fasteningmechanisms of the valve prosthesis. The distal portions of the pluralityof first loop elements may form the second set of fastening mechanismsof the valve prosthesis.

The valve prosthesis may also include a plurality of second loopelements connected to form a ring shape. Each of the second loopelements may include a mid portion and a proximal portion that extendsradially and outwardly away from the mid portion at a first terminal endof the mid portion. The mid portions of the plurality of first loopelements and the mid portions of the plurality of second loop elementsmay form the tubular member. The proximal portions of the plurality offirst loop elements may form the first set of fastening mechanisms, thedistal portions of the plurality of first loop elements may form thesecond set of fastening mechanisms, and the proximal portions of theplurality of second loop elements may form a third set of fasteningmechanisms radially and outwardly disposed from the tubular member andconfigured to attach the valve prosthesis to cardiac tissue at or abovethe heart valve annulus.

The plurality of first loop elements and the plurality of second loopelements may be connected side-by-side in an alternating manner to formthe ring shape. Each of the plurality of second loop elements may beprovided within one of the plurality of first loop elements, and pairsof first and second loop elements may be connected side-by-side to formthe ring shape.

The disclosure also provides a method for treating a lumenal anatomicallocation of a patient. The method includes advancing a distal region ofa delivery catheter proximate a target location in a patient's lumenalsystem, dispensing a penetrating member from the delivery catheterproximate the target location, advancing the penetrating member througha first portion of lumenal tissue proximate the target location todefine a first passage, advancing an end of a first tether through thefirst passage, the first tether having a first anchor disposed at theend thereof, advancing the first tether through the first passage untilthe first anchor bears against tissue proximate the first passage,disposing a prosthesis over the first tether, and advancing theprosthesis over the first tether to a position proximate the targetlocation.

In accordance with further aspects, the method can further includeadvancing the penetrating member through a second portion of lumenaltissue proximate the target location to define a second passage. An endof a second tether can be advanced through the second passage, thesecond tether having a second anchor disposed at the end thereof. Thesecond tether can be advanced through the second passage until thesecond anchor bears against tissue proximate the second passage. Aprosthesis can be disposed over the first and second tethers, and theprosthesis can be advanced over the first and second tethers to aposition proximate the target location.

The method can further include anchoring the prosthesis in place in thetarget location using at least one retainer. The retainer can beattached to the first tether and can urge the prosthesis and anchortoward one another along the first tether. The prosthesis can define anopen lumen upon installation. The method can further include disposing asecond prosthesis within the open lumen. The second prosthesis caninclude a lumenal valve that in turn includes synthetic material and/orliving tissue.

In accordance with a further aspect, the target location can beproximate a patient's mitral annulus. The first and second passages canpass through the commissures of the mitral valve. The target locationcan alternatively proximate a patient's tricuspid valve. If desired, thetarget location can be proximate a patient's abdominal aorta. If so, theprosthesis can include a stent graft. In another embodiment, the targetlocation can be inside a patient's lungs and the prosthesis can includea stent for maintaining patency of an airway. In another embodiment, thetarget location is inside a patient's gastrointestinal tract. Theprosthesis can thus include a stent, such as one for maintaining patencyof a portion of the gastrointestinal tract. In another embodiment, theprosthesis includes a replacement stomach valve.

In still another embodiment, the target location is inside a patient'sreproductive system and the prosthesis can be a stent for maintainingthe patency of a fallopian tube. In another embodiment, the targetlocation can be inside a patient's urinary tract and the prosthesis canbe a stent for maintaining the patency of the patient's urinary tract.

In another embodiment, the prosthesis can include at least one tetherattached thereto, and the disclosed methods can include attaching theprosthesis tether to the first tether to secure the prosthesis in place.

In one embodiment, the delivery catheter can enter the heart through anincision proximate the bottom of the left ventricle. The deliverycatheter can alternatively enters the heart through an incisionproximate the top of the left atrium. Moreover, if desired, the deliverycatheter can enter the heart percutaneously via an artery.

The disclosure further provides a method for treating a lumenalanatomical location. The method includes advancing a distal region of adelivery catheter proximate a target location in a patient's lumenalsystem, and deploying a prosthesis from a distal region of the catheter,the prosthesis having at least one tether connected thereto forcontrolling placement of the prosthesis. If desired, the method canfurther include directing a fixation catheter over the tether to theprosthesis, and applying at least one retainer to secure the prosthesisto the tissue of the patient. The method can likewise include inflatingan inflatable member inside the prosthesis to hold the prosthesis inplace while the fixation catheter is used to secure the prosthesis tothe tissue of the patient.

The disclosure also provides a prosthesis comprising a tubular memberconfigured for deployment in a lumenal system of a patient having atleast one tether extending from the prosthesis for controlling placementof the prosthesis. The disclosure also provides a prosthesis deliverysystem including a central shaft, a prosthesis as discussed hereindisposed on the central shaft, a retractable sheath covering theprosthesis, and a passage in the catheter for housing the least onetether attached to the prosthesis, the conduit having a proximal end anda distal end, the distal end being located proximate the prosthesis.

The disclosure still further provides a prosthesis including a tubularmember configured for deployment in a lumenal system of a patient and atleast one conduit connected to the tubular member, the conduit beingadapted and configured to guide placement of the prosthesis. Similarly,an associated prosthesis delivery system is provided, including acentral shaft, a prosthesis disposed on the central shaft, and at leastone tether passing through the conduit.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, aspects, features, and advantages ofexemplary embodiments will become more apparent and may be betterunderstood by referring to the following description taken inconjunction with the accompanying drawings, in which:

FIG. 1 illustrates a cross-sectional view taken along a longitudinalaxis of an exemplary valve prosthesis in its deployed state.

FIG. 2 illustrates a cross-sectional view taken along a longitudinalaxis of another exemplary valve prosthesis in its deployed state.

FIG. 3 illustrates a cross-sectional view taken along a longitudinalaxis of yet another exemplary valve prosthesis in its deployed state.

FIG. 4 illustrates a cross-sectional view taken along a longitudinalaxis of still another exemplary valve prosthesis in its deployed state.

FIG. 5A illustrates a longitudinal sectional view of a heart thatdepicts the exemplary valve prosthesis of FIG. 3 deployed at the annulusof the mitral valve.

FIG. 5B illustrates a transverse sectional view of the heart of FIG. 5Ain which the exemplary valve prosthesis is deployed at the annulus ofthe mitral valve.

FIG. 6 illustrates a perspective view of an exemplary primary loopconfigured for use and deployment in the posterior region of a heartvalve.

FIG. 7 illustrates a perspective view of an exemplary primary loopconfigured for use and deployment in the anterior region of a heartvalve.

FIG. 8 illustrates a perspective view of an exemplary secondary loopconfigured for deployment in the posterior region of a heart valve.

FIG. 9 illustrates a perspective view of an exemplary secondary loopconfigured for deployment in the anterior region of a heart valve.

FIG. 10 illustrates a perspective view of an exemplary configuration ofa valve prosthesis in which secondary loops (as illustrated in FIG. 8)are disposed within and/or nested within and/or attached to primaryloops (as illustrated in FIG. 6), as configured for deployment in theposterior region of a heart valve.

FIG. 11 illustrates a perspective view of the exemplary loops of FIG. 10where at least a portion of the surface of the primary loops and/or thesecondary loops is covered by a tissue and/or non-tissue graft material(e.g., PS base woven or braided depending on end use applications andrate of tissue growth).

FIG. 12 illustrates a perspective view of an exemplary configuration ofa valve prosthesis in which secondary loops (as illustrated in FIG. 9)are disposed within and/or nested within and/or attached to primaryloops (as illustrated in FIG. 7), as configured for deployment in theposterior region of a heart valve.

FIG. 13 illustrates a perspective view of the exemplary loops of FIG. 12where at least a portion of the surface of the primary loops is coveredby a tissue and/or non-tissue graft material (e.g., PS base woven orbraided depending on end use applications and rate of tissue growth).

FIG. 14 illustrates a perspective view of an exemplary configuration ofa valve prosthesis in which secondary loops (as illustrated in FIG. 8)and primary loops (as illustrated in FIG. 6) are disposed alternately ina side-by-side manner and/or attached to each other, as configured fordeployment in the posterior region of a heart valve.

FIG. 15 illustrates a perspective view of the exemplary loops of FIG. 14where at least a portion of the surface of the primary loops and/or thesecondary loops is covered by a tissue and/or non-tissue graft material.

FIG. 16 illustrates a perspective view of an exemplary configuration ofa valve prosthesis in which secondary loops (as illustrated in FIG. 9)and primary loops (as illustrated in FIG. 7) are disposed alternately ina side-by-side manner and/or attached to each other, as configured fordeployment in the anterior region of a heart valve.

FIG. 17 illustrates a perspective view of the exemplary loops of FIG. 16where at least a portion of the surface of the primary loops and/or thesecondary loops is covered by a tissue and/or non-tissue graft material.

FIG. 18A illustrates a top view of an exemplary valve prosthesis inwhich an anterior portion for deployment in the anterior region of aheart valve is configured differently from a posterior portion fordeployment in the posterior region of a heart valve.

FIG. 18B illustrates a top view of the valve prosthesis of FIG. 18A ascovered with a tissue and/or non-tissue graft material, in its deployedstate.

FIG. 19A illustrates a top view of another exemplary valve prosthesis inwhich an anterior portion for deployment in the anterior region of aheart valve is configured differently from a posterior portion fordeployment in the posterior region of a heart valve.

FIG. 19B illustrates a top view of the valve prosthesis of FIG. 19A ascovered with a tissue and/or non-tissue graft material, in its deployedstate.

FIG. 20 illustrates a cross-sectional view taken through a mitral valvein which an exemplary valve prosthesis is deployed at the annulus of themitral valve and where at least a portion of the surface of theprosthesis is covered by a tissue and/or non-tissue graft material.

FIG. 21 illustrates a cross-sectional view taken through a mitral valvein which an exemplary uncovered valve prosthesis is deployed at theannulus of the mitral valve.

FIGS. 22 and 22A illustrate a cross-sectional view taken through themitral valve shown in FIG. 20 where the valve prosthesis is providedwith radio-opaque markers.

FIG. 23 illustrates a longitudinal sectional view taken through anexemplary valve prosthesis.

FIG. 24 illustrates an exemplary valve prosthesis with a mid portionand/or a distal portion extending below the annular ring that isskirted.

FIG. 25 illustrates a longitudinal section view taken through anexemplary valve prosthesis that is an inverted version of the exemplaryvalve prosthesis of FIG. 23.

FIG. 26 illustrates a longitudinal sectional view taken through anotherexemplary valve prosthesis.

FIG. 27 illustrates an exemplary valve prosthesis with a mid portionand/or a distal portion extending below the annular ring that isskirted.

FIG. 28 illustrates a longitudinal section view taken through anexemplary valve prosthesis that is an inverted version of the exemplaryvalve prosthesis of FIG. 26.

FIG. 29 illustrates a longitudinal section view taken through anexemplary valve prosthesis in which a proximal portion that extendsabove the annular ring into the atrium is skirted.

FIG. 30 illustrates a longitudinal section view taken through anotherexemplary valve prosthesis in which a proximal portion that extendsabove the annular ring into the atrium is skirted.

FIG. 31 illustrates a longitudinal sectional view taken through theexemplary valve prosthesis of FIG. 23 as deployed in the annulus of themitral valve.

FIG. 32 illustrates a longitudinal sectional view taken through theexemplary valve prosthesis of FIG. 26 as deployed in the annulus of themitral valve.

FIG. 33 illustrates a longitudinal sectional view taken through theexemplary valve prosthesis of FIG. 25 as deployed in the annulus of themitral valve.

FIG. 34 illustrates a longitudinal sectional view taken through theexemplary valve prosthesis of FIG. 28 as deployed in the annulus of themitral valve.

FIG. 35 illustrates a longitudinal sectional view taken through theexemplary valve prosthesis of FIG. 29 as deployed in the annulus of themitral valve.

FIG. 36 illustrates a longitudinal sectional view taken through theexemplary valve prosthesis of FIG. 30 as deployed in the annulus of themitral valve.

FIG. 37 illustrates an exemplary delivery device for delivering a valveprosthesis to the annulus of a heart valve.

FIG. 38 illustrates an exemplary valve prosthesis formed of theexemplary loops of FIG. 23 used in replacing a mitral valve.

FIG. 39 illustrates a top view of an exemplary valve prosthesis of FIG.26 deployed in a heart valve annulus showing primary and second loopsabove the annulus.

FIG. 40 illustrates a distal side view of an exemplary valve prosthesisshowing primary and secondary loops.

FIG. 41 illustrates an exemplary valve prosthesis formed of theexemplary loops of FIG. 26 used in replacing a mitral valve.

FIG. 42 illustrates an exemplary valve prosthesis formed of exemplaryloops having a skirted mid and distal portion used in replacing a mitralvalve.

FIG. 43 illustrates an exemplary delivery device for delivering a valveprosthesis to the annulus of a heart valve.

FIG. 44 illustrates an exemplary valve prosthesis that is anchored byone or more anchoring threads that connect to an anchoring mechanism atthe bottom of the ventricular apex.

FIG. 45 illustrates an exemplary valve prosthesis that is anchored byone or more holding strings that connect to an anchoring mechanism at aventricular septal wall.

FIG. 46 illustrates an exemplary valve prosthesis that is anchored tothe posterior region of a heart valve.

FIGS. 47A-47E illustrate left ventricular transapical access of anexemplary delivery device for delivering a valve prosthesis.

FIG. 48 illustrates a further exemplary delivery system for fixationabove and below the mitral annulus.

FIG. 49 illustrates certain aspects of an exemplary portion of adelivery system in accordance with the present disclosure.

FIG. 50 illustrates an alternative embodiment of a portion of a deliverysystem in accordance with the present disclosure.

FIG. 51 illustrates still further aspects of a delivery system inaccordance with the present disclosure.

FIGS. 52A, 53A, 54A, 55A and 56A illustrate a first exemplary method andsystem for disposing a pair of guide rails in the mitral annulus,wherein anchors are disposed on the underside of the annulus of themitral valve by way of the left ventricle.

FIGS. 52B, 53B, 54B, 55B and 56B illustrate a second exemplary methodand system for disposing a pair of guide rails in the mitral annulus,wherein anchors are disposed on the top side of the annulus of themitral valve by way of the left ventricle.

FIG. 57A illustrates an exemplary prosthesis that can serve as a valveprosthesis or open conduit once implanted in accordance with thedisclosure.

FIG. 57B illustrates the prosthesis of FIG. 57A with a pair of guidesfor accepting a pair of guide rails to facilitate implantation of theprosthesis.

FIG. 57C illustrates a half or hemi prosthesis having a pair of guidesfor accepting a pair of guide rails to facilitate implantation of theprosthesis.

FIGS. 58A-58B and 60A illustrate an exemplary placement of a fullprosthesis in the mitral orifice by way of rails anchored from beneaththe mitral annulus.

FIGS. 59A-59B and 60B illustrate an exemplary placement of a halfprosthesis in the mitral orifice by way of rails anchored from beneaththe mitral annulus.

FIGS. 61A and 62A illustrate an exemplary placement of a full prosthesishaving a plurality of tethers attached thereto in the mitral annulus.

FIGS. 61B and 62B illustrate an exemplary placement of a half prosthesishaving a plurality of tethers attached thereto in the mitral annulus.

FIGS. 63A, 63B, 63C, 63D, 63E, and 64A-64B illustrate embodiments oftechniques utilizing rails anchored in valve leaflets.

FIG. 65 illustrates an exemplary method and system for treatment of themitral valve by, inter alia, securing an implant across the mitral valveopening to prevent regurgitation.

FIGS. 66A, 66B, 67A, 68A, 68B, 69-73 illustrate further exemplarymethods and systems for deploying a prosthesis using temporary rails.

DETAILED DESCRIPTION

Exemplary embodiments provide systems, devices and methods for replacinga mitral or tricuspid valve of the heart in a minimally invasive and/orpercutaneous manner. In other embodiments, systems and methods areprovided for repairing other aspects of lumenal systems. Some exemplaryembodiments provide stent-based valve prostheses configured fordeployment at and replacement of the mitral or tricuspid valve of theheart. Valve replacement and other procedures described herein usingexemplary systems, devices and methods as disclosed herein lowers thecost of the overall therapy compared to conventional surgical valvereplacement and allows improved patient care including, but not limitedto, shorter procedure and hospitalization times.

Certain exemplary valve prostheses include looped elements joinedtogether to form radial planes that extend from the longitudinal stentbody of the prosthesis and that fasten the prosthesis against and/or tothe surrounding cardiac anatomy. The spacings between the loop elementsand within each loop element in an exemplary valve prosthesis may beconfigured such that the valve prosthesis is compliant and conforms tothe shape and the anatomy of the valve annulus in a natural manner,without compromising the radial strength for the mid and distal portionsof the loop elements that anchor to the valve tissue. The spacingsbetween the loop elements and within each loop element in an exemplaryvalve prosthesis may be adjusted and covered with tissue, a graft withtissue (e.g., PS base woven or braided depending on end use applicationsand rate of tissue growth), and/or any other suitable material, e.g., aporous layer. In an exemplary embodiment, a graft material may beimpregnated with a tissue growth agent in desired portions of theprosthesis in order to encourage faster tissue growth which, in turn,allows for enhanced prosthesis fixation and lower fatigue.

An exemplary valve prosthesis may be collapsible and may have a firstsmaller diameter or lateral dimension when in a collapsed state. Thevalve prosthesis may be disposed inside a delivery device in thecollapsed state for delivery to a heart valve annulus. An exemplaryvalve may be expandable from its collapsed state and may have a secondlarger diameter when in an expanded and deployed state. The valveprosthesis may self-expand or may be expanded by a catheter upondelivery for deployment at a heart valve annulus. The expansion of thevalve prosthesis allows the prosthesis to naturally conform to theanatomy of the heart valve annulus and allows, in conjunction withfastening mechanisms, secure fastening of the valve prosthesis to thesurrounding cardiac anatomy.

Exemplary valve prostheses may be formed of any suitable materialincluding, but not limited to, stainless steel (e.g., flat or roundspring tempered stainless steel, etc.), one or more shape memory alloyssuch as nickel titanium or NiTi (e.g., in the form of a laser-cut stentor one or more wires set to a particular shape using heat, etc.), DrawnFiled Tubing (DFT) mix of NiTi and Platinum (Pt) or NiTi, etc. Thethickness of the DFT core may be configured and tailored for enhancedradio-opacity and fatigue resistance based on the end use application ofthe valve prosthesis. Portions of exemplary valve prostheses may be bareor grafted with, for example, tissue and/or fabric (e.g., PS base wovenor braided depending on end use applications and rate of tissue growth).

In some exemplary embodiments, one or more inflatable channels may beprovided or attached to the mid and/or distal portions of an exemplaryvalve prosthesis in a radial or series configuration. After deploymentof the prosthesis, the channels may be inflated to provide additionalfriction and fixation, if necessary. In an exemplary embodiment, the midand/or distal portions of a valve prosthesis may be impregnated with ahydrophobic material that may be released in a timed manner. Afterdeployment of the prosthesis, the material may be activated and may actas a sponge, thereby providing additional friction and fixation.

FIGS. 1-4 illustrate cross-sectional views taken along a longitudinalaxis L of an exemplary stented valve prostheses in their deployed state.

FIG. 1 illustrates a cross-sectional view taken along the longitudinalaxis L of an exemplary stented valve prosthesis 100 including a proximalportion 102 that is configured to fasten or secure the valve prosthesis100 to the atrium, a mid portion 104 that is disposed in the annulus ofa heart valve (e.g., the mitral valve or the tricuspid valve), and adistal portion 106 that is configured to fasten or secure the valveprosthesis 100 to the ventricle.

The proximal portion 102 of the valve prosthesis 100 may include one ormore annular size reducers 108 that extend radially about the proximalportion 102 in spaced apart fashion to form a ring shape. The annularsize reducers 108 configure the valve prosthesis 100 to have a smallervalve size, while fastening the valve prosthesis 100 securely and in acompliant manner to the atrium and the ventricle. The annular sizereducers 108 can also prevent paravalvular leaks that may occur throughsmall openings or spaces that may exist between the heart and the valveprosthesis 100.

The proximal portion 102 may include one or more fastening, anchoring orbracing mechanisms 110 for fastening the valve prosthesis 100 to anupper portion of the region of the heart in which the valve prosthesis100 is deployed. In an exemplary embodiment in which the valveprosthesis 100 is deployed to replace the mitral valve, the fasteningmechanism 110 may be used to fasten the valve prosthesis 100 to/againstthe left atrium or to/against an upper portion of the annulus of themitral valve. In another exemplary embodiment in which the valveprosthesis 100 is deployed to replace the tricuspid valve, the fasteningmechanism 110 may be used to fasten the valve prosthesis 100 to theright atrium or to an upper portion of the annulus of the tricuspidvalve.

The fastening mechanism 110 may form a compliant structure that conformsto the anatomy of the surrounding heart tissue and that, therefore,securely fastens the valve prosthesis 100 to the surrounding hearttissue. Exemplary fastening mechanisms 110 may include individual ormultiple palm-like contoured anchoring, fastening or bracing mechanisms.Exemplary fastening mechanisms 110 may be formed of the radiallyextending proximal portions of a connected series of loop elements.

In an exemplary embodiment, the fastening mechanism 110 includes one ormore arcuate structures that initially extend radially and outwardly ina substantially perpendicular direction relative to the stent body 114of the valve prosthesis 100, and that transition to a downward arctoward the distal portion 106 until reaching a terminal end 112. Thefastening mechanism 110 extends above the valve leaflets such that theleaflets are disposed under the arcuate structure and such that the end112 of the arcuate structure fastens the valve prosthesis 100 to hearttissue found above and/or near the valve leaflets.

The proximal portion 102 may also include one or more mechanisms forholding, repositioning, retrieving and releasing the valve prosthesis100 to be used during deployment of the valve prosthesis 100 to theannulus of a heart valve by a delivery system, discussed in furtherdetail below.

The mid portion 104 of the valve prosthesis 100 includes a stent body114 having a bore configured to be placed within the annulus of a heartvalve. At its top end, the stent body 114 opens into an annulus 116 ofthe heart valve. In exemplary embodiments, one or more radio-opaquemarkers may be placed on the stent body 114 to facilitate in positioningand deploying the valve prosthesis 100 by a delivery system. The markersmay also enhance physician feedback and a tactile feeling. Theradio-opaque markers may be placed only on the posterior side of thestent body 114, only on the anterior side of the stent body 114, or onboth posterior and anterior sides of the stent body 114. Exemplarymarkers may include, but are not limited to, radial markers, individualmarkers, pad printed markers and/or woven monofilament markers.

A portion of the outer surface of the proximal portion 102 and/or aportion of the outer surface of the mid portion 104 may include acompliant pocket 120 that is configured to further eliminateparavalvular leaks around the valve prosthesis 100. In an exemplaryembodiment, the compliant pocket 120 is mounted on the stent body 114and extends radially around the stent body 114. In an exemplaryembodiment, the compliant pocket 120 may extend to the distal portion106 of the valve prosthesis. The compliant pocket 120 may alsofacilitate fastening and anchoring of the valve prosthesis 100 to thesurrounding cardiac anatomy while minimizing damage to cardiac tissue.The compliant pocket 120 may enhance the overall compliance integrity ofthe valve prosthesis 100 and fatigue resistance.

In an exemplary embodiment, the outer surface of the compliant pocket120 may be impregnated with tissue growth and/or with a coating ofanother material to keep the outer surfaces of the valve prosthesis 100on the anterior side away from the anterior region of the mitral valve.This configuration protects the cardiac anatomy in the anterior regionof the heart from inadvertent damage caused by the valve prosthesis 100.In other exemplary embodiments, the outer surface of the compliantpocket 120 may be impregnated with tissue growth and/or with a coatingof another material on the anterior side of the prosthesis, on theposterior side of the prosthesis, or on both the anterior and posteriorsides of the prosthesis. The compliant pocket 120 may have a porousexterior layer, e.g., a cushioned layer, that extends on the posteriorside, the anterior side, or both the posterior and anterior sides. Theporous exterior layer may enhance the overall system compliance,integrity and fatigue resistance. The porous exterior layer may beimpregnated with tissue growth and/or other coatings.

The distal portion 106 of the valve prosthesis 100 includes one or morefastening, anchoring or bracing mechanisms 122 for fastening the valveprosthesis 100 to a lower portion of the region of the heart in whichthe valve prosthesis 100 is deployed. In an exemplary embodiment inwhich the valve prosthesis 100 is deployed to replace the mitral valve,the fastening mechanism 122 may be used to fasten the valve prosthesis100 to the left ventricle or to a lower portion of the annulus of themitral valve. In another exemplary embodiment in which the valveprosthesis 100 is deployed to replace the tricuspid valve, the fasteningmechanism 122 may be used to fasten the valve prosthesis 100 to theright ventricle or to a lower portion of the annulus of the tricuspidvalve.

The fastening mechanism 122 may form a compliant structure that conformsto the anatomy of the surrounding heart tissue (or otherwise, asdisclosed below) and that, therefore, securely fastens the valveprosthesis 100 to the surrounding heart tissue. Exemplary fasteningmechanisms 122 may include individual or multiple palm-like contouredanchoring, fastening or bracing mechanisms. Exemplary fasteningmechanisms 122 may be formed of the radially extending proximal portionsof a connected series of loop elements.

In an exemplary embodiment, the fastening mechanism 122 includes one ormore arcuate structures that initially extend outwardly in asubstantially perpendicular direction relative to the stent body 114 ofthe valve prosthesis 100, and that transition to an upward arc towardthe proximal portion 102. The fastening mechanism 122 extends below thevalve leaflets such that leaflets are disposed above the arcuatestructure and such that the end of the arcuate structure fastens thevalve prosthesis 100 to heart tissue found under and/or near the valveleaflets.

In an exemplary embodiment, the fastening mechanism 122 is anchoredunderneath one or both of the two mitral valve commissures. In thisexemplary embodiment, the fastening mechanism 122 may include two setsof arcuate structures placed about 180 degrees apart on the stent body114 to engage both the mitral valve commissures. Each set of arcuatestructures may include one or more arcuate structures. The arcuatestructures may extend radially about the outer surface of the stent body114 in a spaced apart manner.

The distal portion 106 may also include one or more mechanisms forholding, repositioning, retrieving and releasing the valve prosthesis100 to be used during deployment of the valve prosthesis 100 to theannulus of a heart valve by a delivery system.

FIG. 2 illustrates a cross-sectional view taken along a longitudinalaxis of another exemplary stented valve prosthesis 200 in its deployedstate. The valve prosthesis 200 includes a proximal portion 202 that isconfigured to fasten the valve prosthesis 200 to the atrium and a midportion 204 that is disposed in the annulus of a heart valve. The valveprosthesis 200 lacks a distal portion configured to fasten the valveprosthesis 200 to the ventricle.

The proximal portion 202 of the valve prosthesis 200 may include one ormore annular size reducers 208 that configure the valve prosthesis 200to have a smaller valve size while fastening the valve prosthesissecurely and in a compliant manner to the atrium and the ventricle. Theannular size reducers 208 extend radially about the proximal portion 202in spaced apart fashion to form a ring shape. The proximal portion 202of the valve prosthesis 200 lacks a compliant pocket in thisillustrative embodiment.

The proximal portion 202 may include one or more fastening, anchoring orbracing mechanisms 210 for fastening the valve prosthesis 200 to anupper portion of the region of the heart in which the valve prosthesis200 is deployed. The fastening mechanism 210 may form a compliantstructure that conforms to the anatomy of the surrounding heart tissueand that, therefore, securely fastens the valve prosthesis 200 to thesurrounding heart tissue. The fastening mechanism 210 extends above thevalve leaflets such that leaflets are disposed under the arcuatestructure and such that the end 212 of the arcuate structure fastens thevalve prosthesis 200 to heart tissue found above and/or near the valveleaflets.

The mid portion 204 of the valve prosthesis 200 includes a stent body214 having a bore configured to be placed within the annulus of a heartvalve. At its top end, the stent body 214 opens into an annulus 216 ofthe heart valve.

FIG. 3 illustrates a cross-sectional view taken along a longitudinalaxis of another exemplary stented valve prosthesis 300 in its deployedstate. The valve prosthesis 300 includes a proximal portion 302 that isconfigured to fasten the valve to the atrium, a mid portion 304 that isdisposed in the annulus of a heart valve, and a distal portion 306 thatis configured to fasten the valve prosthesis 300 to the ventricle.

The proximal portion 302 of the valve prosthesis 300 may include one ormore annular size reducers 308 that configure the valve prosthesis 300to have a smaller valve size while fastening the valve prosthesissecurely and in a compliant manner to the atrium and the ventricle. Theannular size reducers 308 extend radially about the proximal portion 302in spaced apart fashion to form a ring shape. The proximal portion 302of the valve prosthesis 300 lacks a compliant pocket.

The proximal portion 302 may include one or more fastening, anchoring orbracing mechanisms 310 for fastening the valve prosthesis 300 to anupper portion in the region of the heart in which the valve prosthesis300 is deployed. The fastening mechanism 310 may form a compliantstructure that conforms to the anatomy of the surrounding heart tissueand that, therefore, securely fastens the valve prosthesis 300 to thesurrounding heart tissue. The fastening mechanism 310 extends above thevalve leaflets such that leaflets are disposed under the arcuatestructure and such that the end 312 of the arcuate structure fastens thevalve prosthesis 300 to heart tissue found above and/or near the valveleaflets.

The mid portion 304 of the valve prosthesis 300 includes a stent body314 having a bore configured to be placed within the annulus of a heartvalve. At its top end, the stent body 314 opens into an annulus 316 ofthe heart valve.

The distal portion 306 of the valve prosthesis 300 includes one or morefastening, anchoring or bracing mechanisms 322 for fastening the valveprosthesis 300 to a lower portion in the region of the heart in whichthe valve prosthesis 300 is deployed. The fastening mechanism 322 mayform a compliant structure that conforms to the anatomy of thesurrounding heart tissue and that, therefore, securely fastens the valveprosthesis 300 to the surrounding heart tissue.

FIG. 4 illustrates a cross-sectional view taken along a longitudinalaxis of another exemplary stented valve prosthesis 400 in its deployedstate. The valve prosthesis 400 includes a proximal portion 402 that isconfigured to fasten the valve to the atrium and a mid portion 404 thatis disposed in the annulus of a heart valve. The proximal portion 402 ofthe valve prosthesis 400 has a compliant pocket 406. The valveprosthesis 400 lacks a distal portion configured to fasten the valveprosthesis 400 to the ventricle.

The proximal portion 402 of the valve prosthesis 400 may include one ormore annular size reducers 408 that configure the valve prosthesis 400to have a smaller valve size while fastening the valve prosthesissecurely and in a compliant manner to the atrium and the ventricle. Theannular size reducers 408 extend radially about the proximal portion 402in spaced apart fashion to form a ring shape. The proximal portion 402of the valve prosthesis 400 includes a compliant pocket 420 that isconfigured to further eliminate paravalvular leak around the valveprosthesis 400. The compliant pocket 420 may also facilitate fasteningand anchoring of the valve prosthesis 400 to the surrounding cardiacanatomy, while minimizing damage to cardiac tissue.

The proximal portion 402 may include one or more fastening, anchoring orbracing mechanisms 410 for fastening the valve prosthesis 400 to anupper portion in the region of the heart in which the valve prosthesis400 is deployed. The fastening mechanism 410 may form a compliantstructure that conforms to the anatomy of the surrounding heart tissueand that, therefore, securely fastens the valve prosthesis 400 to thesurrounding heart tissue. The fastening mechanism 410 extends above thevalve leaflets such that leaflets are disposed under the arcuatestructure and such that the end 412 of the arcuate structure fastens thevalve prosthesis 400 to heart tissue found above and/or near the valveleaflets.

The mid portion 404 of the valve prosthesis 400 includes a stent body414 having a bore configured to be placed within the annulus of a heartvalve. At its top end, the stent body 414 opens into an annulus 416 ofthe heart valve.

FIG. 5A illustrates a longitudinal sectional view of a heart that showsthe exemplary valve prosthesis of FIG. 3 deployed at the annulus of themitral valve. FIG. 5A depicts a heart 500 with the mitral valve annulus502 formed between the left atrium 504 and the left ventricle 506. Theexemplary valve prosthesis 508 of FIG. 3 is deployed at the mitral valveannulus 502 to replace the mitral valve. The mid portion 510 forming thestent body 508 of the valve prosthesis 500 is positioned in and contactsthe annulus of the mitral valve and extends into the left ventricle. Theproximal portion 512 of the valve prosthesis 500 is disposed above thevalve leaflets in an exemplary embodiment, or above where the leafletswould be in another exemplary embodiment in which the valve leaflets areremoved. One or more fastening mechanisms in the proximal portion 512anchor the valve prosthesis 500 to the walls of the left atrium abovethe valve leaflets. The distal portion 514 of the valve prosthesis 500is disposed under the valve leaflets. One or more fastening mechanismsin the distal portion 514 anchor the valve prosthesis 500 to the wallsof the left ventricle under the valve leaflets.

That is, in an exemplary embodiment, the proximal portion of the valveprosthesis 500 is fastened to the left atrium by one or more fasteningmechanisms and the distal portion of the valve prosthesis 500 isfastened to the left ventricle by one or more fastening mechanisms. Thecombination of the fastening mechanisms securely anchors the valveprosthesis 500 both above and below the annulus of the heart valve. Inother exemplary embodiments, additional fastening mechanisms may beprovided to fasten the valve prosthesis 500 to cardiac tissue in theannulus of the heart valve.

FIG. 5B illustrates a transverse sectional view of the heart 500 of FIG.5A in which the valve prosthesis 508 is deployed in the mitral valve.The top view of the valve leaflets is obscured by the proximal portion512 of the valve prosthesis 508 which extends over the valve leafletsand fastens the valve prosthesis to the left atrium.

Exemplary valve prostheses 100, 200 and 400 illustrated in FIGS. 1, 2and 4, respectively, may be deployed at a mitral or a tricuspid valve ina manner similar to the exemplary deployment of the valve prosthesisshown in FIGS. 5A and 5B.

A valve prosthesis may include one or more series of loop elements, eachseries of looped elements being connected to form a looped structure.The looped structures may be disposed along the circumference of theannulus of a heart valve, and may provide uniform support of the valveprosthesis against the annulus of a heart valve. In an exemplaryembodiment in which the prosthesis is configured for deployment at amitral valve, the looped structures forming the prosthesis may besubstantially D-shaped to conform naturally to the substantiallyD-shaped cross-section of the mitral valve. In an exemplary embodimentin which the prosthesis is configured for deployment at a tricuspidvalve, the looped structures forming the prosthesis may be substantiallycircular in shape when deployed to conform naturally to thesubstantially circular cross-section of the tricuspid valve.

Exemplary valve prostheses may include one or more types of loopelements, e.g., primary loops and/or secondary loops. A looped structureformed of a connected series of loop elements may include single type ofloop element (e.g., primary loops or secondary loops) or may include twoor more types of loop elements (e.g., primary and secondary loops). Inan exemplary embodiment, the primary loops may be longer along thelongitudinal axis L than the secondary loops.

FIG. 6 illustrates a perspective view of an exemplary primary loop 600configured for use and deployment in the posterior region of a heartvalve. An exemplary primary loop 600 includes a mid portion 602 that isformed of two or more substantially straight segments, such as firstsegment 604 and second segment 606 that extend substantially parallel toeach other. In other exemplary embodiments, the segments 604 and 608 maynot be straight. The mid portion 602 is configured to be positioned inthe heart valve annulus adjacent to the heart wall in the valve annulus,such that the straight segments 604 and 606 extend along thelongitudinal axis L of the heart valve annulus.

In an exemplary embodiment, additional support structures, e.g., one ormore struts, may be included in the mid portion 602 to tailor thecompliance of the mid portion 602 to the annulus of the heart valve. Thesupport structures may include one or more zigzagging struts that extendacross the mid portion 602 along the circumference of the valveprosthesis. In an exemplary embodiment, the struts may extend across themid portion 602 in a substantially serpentine configuration.

An exemplary primary loop 600 includes a proximal portion 608 that formsa first terminal end of the loop element. The proximal portion 608 iscurved and extends radially and outwardly away from the longitudinalaxis L of the valve prosthesis in an arcuate manner. The tip 610 of theproximal portion 608 curves downwardly to some extent in an exemplaryembodiment. The proximal portion 608 is configured to be positioned justabove the annular ring of the heart valve such that the arcuate shape ofthe proximal portion 608 provides a fastening mechanism for radialfastening of the valve prosthesis to the atrium or to an upper portionof the heart valve annulus. The fastening mechanism also provides anouter radial force against the top of the heart valve annulus whichsecurely attaches the valve prosthesis to the heart valve annulus. Inthe looped structure formed by multiple primary loops 600, the proximalportions 608 adapt to the shape of the annulus of a heart valve andprovide natural coverage and a complete radial seal that eliminatesparavalvular leaks. In an exemplary embodiment, the tip 610 of theproximal portion 608 may be adjustable and may include a sharp end,e.g., a barb, to penetrate the valve annulus to further secure the valveprosthesis to the annulus.

In the exemplary embodiment, the primary loop 600 includes a distalportion 612 that forms a second terminal end of the loop element. Thedistal portion 612 is curved and extends radially and outwardly awayfrom the longitudinal axis L of the valve prosthesis in an arcuatemanner. The tip 614 of the distal portion 612 curves upwardly to someextent in an exemplary embodiment. The distal portion 612 is configuredto be positioned under the valve leaflets such that the arcuate shape ofthe distal portion 612 provides a fastening mechanism for radialfastening of the valve prosthesis to the ventricle below the valveleaflets. The fastening mechanism also provides an outer radial forceagainst the valve annulus which securely attaches the valve prosthesisto the valve annulus and that provides a radial seal between the outersurface of the valve prosthesis and the annulus of a heart valve toprevent paravalvular leaks.

In exemplary embodiments, the proximal portions 608 and/or distalportions 612 of the primary loops 600 are flexible, and the curvatureand mushroom shape formed by the looped series of primary loops 600 areautomatically adjustable, e.g., by adjusting the curvature radium, dueto the flexible nature of the proximal and/or distal portions. Thisadjustability allows for adjusting the shape of the annulus formed bythe valve prosthesis. This allows an exemplary valve prosthesis toconform to the annular shape of any heart valve. That is, a loopedseries of connected primary loops may be placed in any heart valveannulus, and the compliant nature of the loops will allow the prosthesisto conform to the particular structure of the valve annulus. As such,one size of the valve prosthesis may fit any annulus and this may reducethe overall delivery profile of the prosthesis for a delivery device andmay, consequently, reduce the access puncture point and improvedeliverability and tactile feeling of the valve prosthesis. In addition,a clinically relevant smaller valve annulus size may have improved shelflife.

FIG. 7 illustrates a perspective view of an exemplary primary loop 700configured for use and deployment in the anterior region of a heartvalve. The exemplary primary loop 700 lacks the distal portion, e.g.,similar to the distal portion 612 in FIG. 6. That is, in exemplaryprimary loop 700, the second terminal end of the loop element is notcurved and does not extend radially outwardly and away from thelongitudinal axis L of the valve prosthesis in an arcuate manner.

The proximal portions and/or the distal portions of the primary loopsmay also include one or more mechanisms for holding, repositioning,retrieving and releasing the valve prosthesis to be used duringdeployment of the valve prosthesis to the heart valve annulus by adelivery system. In exemplary embodiments, the proximal portions, themid portions and/or the distal portions of the primary loops may becovered with tissue, a graft with tissue (e.g., PS base woven or braideddepending on end use applications and rate of tissue growth), and/or anyother suitable material, e.g., a porous layer.

In exemplary embodiments, one or more markers, e.g., radio-opaquemarkers, may be placed along the radial length of the proximal, midand/or distal portions of the primary loops. The markers may take theform of bands or pad prints in some exemplary embodiments.

FIG. 8 illustrates a perspective view of an exemplary secondary loop 800configured for use and deployment in the posterior region of a heartvalve. The exemplary secondary loop 800 includes a mid portion 802 thatis formed of two or more substantially straight segments 804 and 806that extend substantially parallel to each other. The mid portion 802 isconfigured to be positioned in the heart valve annulus and adjacent tothe heart wall in the heart valve annulus, such that the straightsegments 804 and 806 extend along the longitudinal axis L of the heartvalve annulus.

In an exemplary embodiment, additional support structures, e.g., struts,may be included in the mid portion 802 to tailor the compliance of themid portion 802 to the annulus of the heart valve. The supportstructures may include one or more zigzagging struts that extend acrossthe mid portion 802 along the circumference of the valve prosthesis. Inan exemplary embodiment, the struts may extend across the mid portion802 in a substantially serpentine configuration. Exemplary supportstructures may be included in any of the exemplary primary and/orsecondary loops described herein.

An exemplary secondary loop 800 includes a proximal portion 808 thatforms a first terminal end of the loop element. The proximal portion 808is curved and extends radially outwardly and away from the longitudinalaxis L of the valve prosthesis in an arcuate manner. The tip 810 of theproximal portion 808 curves downwardly to some extent in an exemplaryembodiment. In an exemplary embodiment, the proximal portion 808 isconfigured to be positioned in the heart valve annulus such that thearcuate shape of the proximal portion 808 provides a fastening mechanismfor attaching the valve prosthesis to the heart wall in the annulus. Inanother exemplary embodiment, the proximal portion 808 is configured tobe positioned over the valve leaflets such that the arcuate shape of theproximal portion 808 provides a fastening mechanism for attaching thevalve prosthesis to the atrium or to an upper portion of the valveannulus. In exemplary embodiments, the proximal portions 808 of thesecondary loops 800 provide a spacing between the heart valve and thevalve prosthesis. In an exemplary embodiment, the tip 810 of theproximal portion 800 may be adjustable and may include a sharp end,e.g., a barb, to penetrate the valve annulus to further secure the valveprosthesis to the annulus.

In an exemplary embodiment, the secondary loop 800 includes a distalportion 812 that forms a second terminal end of the loop element. Thedistal portion 812 is curved and extends radially outwardly and awayfrom the mid portion 802 of the valve prosthesis in an arcuate manner.The tip 814 of the distal portion 812 curves upwardly to some extent inan exemplary embodiment. In an exemplary embodiment, the distal portion812 is configured to be positioned in the valve annulus such that thearcuate shape of the distal portion 812 provides a fastening mechanismfor radially fastening the valve mechanism to the heart wall in theannulus. In another exemplary embodiment, the distal portion 812 isconfigured to be positioned under the valve leaflets such that thearcuate shape of the distal portion 812 provides a fastening mechanismfor radially fastening the valve prosthesis to the ventricle below thevalve leaflets. The fastening mechanism also provides an outer radialforce against the valve annulus which securely attaches the valveprosthesis to the heart valve annulus and that provides a radial sealbetween the outer surface of the valve prosthesis and the heart valveannulus to prevent paravalvular leaks.

FIG. 9 illustrates a perspective view of an exemplary secondary loop 900configured for deployment in the anterior region of a heart valve. Thesecondary loop 900 lacks the distal portion (e.g., the distal portion812 illustrated in FIG. 8). That is, in exemplary secondary loop 900,the second terminal end of the loop element is not curved and does notextend radially outwardly and away from the longitudinal axis L of thevalve prosthesis in an arcuate manner.

The proximal portions and/or the distal portions of the secondary loopsmay also include one or more mechanisms for holding, repositioning,retrieving and releasing the valve prosthesis to be used duringdeployment of the valve prosthesis to the heart valve annulus by adelivery system. In exemplary embodiments, the proximal portions, themid portions and/or the distal portions of the secondary loops may becovered with tissue, a graft with tissue (e.g., PS base woven or braideddepending on end use applications and rate of tissue growth), and/or anyother suitable material, e.g., a porous layer. The proximal portions ofthe secondary loops, covered with a layer or uncovered, may act ascompliant spacers between the native tissue valve and the valveprosthesis. In exemplary embodiments, the mid portions of the secondaryloops may act as a spacer and radial support between the valveprosthesis and the native tissue valve.

In exemplary embodiments, one or more markers, e.g., radio-opaquemarkers, may be placed along the radial length of the proximal, midand/or distal portions of the secondary loops. The markers may take theform of bands or pad prints in some exemplary embodiments.

In exemplary embodiments, the primary loops may all have the same sizeand configuration or may have varied sizes and configurations. Inexemplary embodiments, the secondary loops may all have the same sizeand configuration or may have varied sizes and configurations. In anexemplary embodiment, the secondary loops are smaller in size than theprimary loops.

In an exemplary embodiment, the anterior and posterior regions of thevalve prosthesis, respectively configured for deployment in the anteriorand posterior regions of a heart valve, have the same structuralconfiguration. In exemplary embodiments suitable for application inmitral and tricuspid valves of the heart, the valve prosthesis isconfigured differently in its anterior region and its posterior regionrespectively configured for deployment in the anterior and posteriorregions of a heart valve. In exemplary embodiments, the anterior andposterior regions of the valve prosthesis may be configured such thatthe radial extensions and/or radial lengths of the proximal and distalportions of the loops are configured differently for the anterior andposterior regions. In exemplary embodiments, the anterior and posteriorregions of the valve prosthesis may be configured such that the primaryand/or secondary loops in the anterior regions have different structuralconfigurations than the primary and/or secondary loops in the posteriorregions. As illustrated in FIGS. 6 and 8, the primary loops 600 andsecondary loops 800 configured for deployment in the posterior region ofa heart valve may include the distal portions 612 and 812, respectively.As illustrated in FIGS. 7 and 9, the primary loops 700 and secondaryloops 900 configured for deployment in the anterior region may lack thedistal portions for improved safety and for efficacy of the valvereplacement procedure, while securing the valve prosthesis against theaortic valve and the aortic trunk. The lack of the distal portions inthe anterior region protects the aortic valve and the aortic trunk thatare present in the anterior region of the heart from inadvertent damagecaused by radially extending distal portions.

As illustrated in FIGS. 6 and 7, in exemplary embodiments, the primaryloops 600 configured for deployment in the anterior region may haveproximal portions 608 that are curved in a more exaggerated arcuateshape than the proximal portions 708 of the primary loops 700 that areconfigured for deployment in the anterior region of a heart valve. Thatis, the proximal portion 708 may curve downward from the transverse axisT toward the distal portion of the loop element to a greater extent thanthe proximal portion 608 curves downward from the transverse axis Ttoward the distal portion of the loop element.

Similarly, as illustrated in FIGS. 8 and 9, in exemplary embodiments,the secondary loops 900 configured for deployment in the anterior regionof a heart valve may have proximal portions 908 that are curved in amore exaggerated arcuate shape than the proximal portions 808 of thesecondary loops 800 that are configured for deployment in the posteriorregion of a heart valve. That is, the proximal portion 908 may curvedownward from the transverse axis T toward the distal portion of theloop to a greater extent than the proximal portion 808 curves downwardfrom the transverse axis T toward the distal portion of the loop. Thedifferent configurations of the loop elements allow the anterior andposterior portions of the valve prosthesis to closely conform to thesurrounding anterior and posterior anatomy, respectively, of the heart.

The primary and secondary loops in the posterior region may act ascompliant spacers between the posterior region of the heart and thevalve prosthesis.

In the assembled valve prosthesis, the primary and secondary loopelements may be connected together with their centers substantiallyaligned along a radial plane. The loop elements may be connected bysutures or may be laser-cut to form a contiguous or substantiallycontiguous looped structure extending radially about a radial plane.

In exemplary embodiments illustrated in FIGS. 10-13, the primary loopsconnected side-by-side in series to form a looped structure that fitsinto a heart valve annulus and that supports the valve prosthesisagainst the annulus of the heart valve. The secondary loops are providedwithin and/or nested within the primary loops.

FIG. 10 illustrates a perspective view of an exemplary configuration ofa valve prosthesis in which secondary loops 800 (as illustrated in FIG.8) are disposed within and/or nested within primary loops 600 (asillustrated in FIG. 6), as configured for deployment in the posteriorregion of a heart valve. The primary loops 600 are aligned with eachother and connected side-by-side to form a looped structure that can fitinto the annulus of a heart valve. In the looped structure formed by theprimary loops 600, the proximal portions 608 of the primary loops 600are aligned along a first radial plane, and the distal portions 612 ofthe primary loops 600 are aligned along a second radial plane. In anexemplary embodiment, the primary loops 600 are connected side-by-side,leaving an amount of spacing between adjacent primary loops. In anotherexemplary embodiment, the primary loops 600 are connected side-by-side,leaving no or negligible spacing between adjacent primary loops.

The secondary loops 800 are aligned with each other to form a loopedstructure that can fit into the annulus of a heart valve. In the loopedstructure formed by the secondary loops 800, the proximal portions 808of the secondary loops 800 are aligned along a third radial plane, andthe distal portions 812 of the secondary loops 800 are aligned along afourth radial plane.

In exemplary embodiments, the secondary loops 800 are connected to theprimary loops 600 to form an integral valve prosthesis. In the exemplaryembodiment illustrated in FIGS. 10 and 11, the secondary loops 800 aredisposed within and/or nested within the primary loops 600. In anexemplary embodiment, the centers of the mid portions 602 of the primaryloops 600 and the mid portions 802 of the secondary loops 800 arealigned along a centerline C. The entire mid portions 802 of thesecondary loops 800 may fit within the longer mid portions 602 of theprimary loops 600.

In an exemplary embodiment, each secondary loop 800 may be connected tothe primary loop 600 that the secondary loop is disposed within. In anexemplary embodiment, there is a amount of space between each secondaryloop 800 and the corresponding primary loop 600 to which the secondaryloop is connected. In another exemplary embodiment, there is no ornegligible spacing between each secondary loop 800 and the correspondingprimary loop 600 to which the secondary loop is connected.

In another exemplary embodiment, the secondary loops 800 may be alignedwith each other and connected side-by-side to form a looped structure.In an exemplary embodiment, the secondary loops 800 are connectedside-by-side, leaving an amount of spacing between adjacent secondaryloops. In another exemplary embodiment, the secondary loops 800 areconnected side-by-side, leaving no or negligible spacing betweenadjacent secondary loops.

FIG. 11 illustrates a perspective view of the exemplary loops of FIG. 10where at least a portion of the surface of the primary loops 600 and/orthe secondary loops 800 is covered by a tissue and/or non-tissue graftmaterial 1106 (e.g., PS base woven or braided depending on end useapplications and rate of tissue growth).

FIG. 12 illustrates a perspective view of an exemplary configuration ofa valve prosthesis in which secondary loops 900 (as illustrated in FIG.9) are disposed within and/or nested within primary loops 700 (asillustrated in FIG. 7), as configured for deployment in the posteriorregion of a heart valve. The primary loops 700 are aligned with eachother and connected side-by-side to form a looped structure that can fitinto the annulus of a heart valve. In the looped structure formed by theprimary loops 700, the proximal portions 708 of the primary loops 700are aligned along a first radial plane. In an exemplary embodiment, theprimary loops 700 are connected side-by-side, leaving an amount ofspacing between adjacent primary loops. In another exemplary embodiment,the primary loops 700 are connected side-by-side, leaving no ornegligible spacing between adjacent primary loops.

The secondary loops 900 are aligned with each other to form a loopedstructure that can fit into the annulus of a heart valve. In the loopedstructure formed by the secondary loops 900, the proximal portions 908of the secondary loops 900 are aligned along a first radial plane.

In exemplary embodiments, the secondary loops 900 are connected to theprimary loops 700 to form an integral valve prosthesis. In the exemplaryembodiment illustrated in FIGS. 12 and 13, the secondary loops 900 aredisposed within and/or nested within the primary loops 700. In anexemplary embodiment, the centers of the mid portions 702 of the primaryloops 700 and the mid portions 902 of the secondary loops 900 arealigned along a centerline C. The entire mid portions 902 of thesecondary loops 900 may fit within the longer mid portions 702 of theprimary loops 700.

In an exemplary embodiment, each secondary loop 900 may be connected tothe primary loop 700 that the secondary loop is disposed within. In anexemplary embodiment, there is a amount of space between each secondaryloop 900 and the corresponding primary loop 700 to which the secondaryloop is connected. In another exemplary embodiment, there is no ornegligible spacing between each secondary loop 900 and the correspondingprimary loop 700 to which the secondary loop is connected.

In another exemplary embodiment, the secondary loops 900 may be alignedwith each other and connected side-by-side to form a looped structure.In an exemplary embodiment, the secondary loops 900 are connectedside-by-side, leaving an amount of spacing between adjacent secondaryloops. In another exemplary embodiment, the secondary loops 900 areconnected side-by-side, leaving no or negligible spacing betweenadjacent secondary loops.

FIG. 13 illustrates a perspective view of the exemplary loops of FIG. 12where at least a portion of the surface of the primary loops 700 and/orthe secondary loops 900 is covered by a tissue and/or non-tissue graftmaterial 1306 (e.g., PS base woven or braided depending on end useapplications and rate of tissue growth).

In other exemplary embodiments illustrated in FIGS. 14-17, the primaryloops and the secondary loops are alternately connected side-by-side inseries to form a looped structure formed of alternating primary andsecondary loops that fits into a heart valve annulus and that supportsthe valve prosthesis against the annulus of the heart valve. That is,each primary loop is connected at each side to a secondary loop, andeach secondary loop is connected at each sides to a primary loop.

FIG. 14 illustrates a perspective view of an exemplary configuration ofa valve prosthesis in which secondary loops 800 (as illustrated in FIG.8) and primary loops 600 (as illustrated in FIG. 6) are disposedalternately in a side-by-side manner, as configured for deployment inthe posterior region of a heart valve. The primary loops 600 andsecondary loops 800 are aligned with each other and connectedside-by-side to form a looped structure that can fit into the annulus ofa heart valve. Each primary loop 600 is connected at each side to asecondary loop 800, and each secondary loop 800 is connected at eachside to a primary loop 600 to form an integral valve prosthesis.

In the looped structure formed by the primary loops 600 and thesecondary loops 800, the proximal portions 608 of the primary loops 600are aligned along a first radial plane, the distal portions 612 of theprimary loops 600 are aligned along a second radial plane, the proximalportions 808 of the secondary loops 800 are aligned along a third radialplane, and the distal portions 812 of the secondary loops 800 arealigned along a fourth radial plane.

In an exemplary embodiment, the loops are connected side-by-side,leaving an amount of spacing between adjacent loops. In anotherexemplary embodiment, the loops are connected side-by-side, leaving noor negligible spacing between adjacent loops.

In an exemplary embodiment, the centers of the mid portions 602 of theprimary loops 600 and the mid portions 802 of the secondary loops 800are aligned along a centerline C.

FIG. 15 illustrates a perspective view of the exemplary loops of FIG. 14where at least a portion of the surface of the primary loops 600 and/orthe secondary loops 800 is covered by a tissue and/or non-tissue graftmaterial 1506 (e.g., PS base woven or braided depending on end useapplications and rate of tissue growth).

FIG. 16 illustrates a perspective view of an exemplary configuration ofa valve prosthesis in which secondary loops 900 (as illustrated in FIG.9) and primary loops 700 (as illustrated in FIG. 7) are disposedalternately in a side-by-side manner, as configured for deployment inthe anterior region of a heart valve. The primary loops 700 andsecondary loops 900 are aligned with each other and connectedside-by-side to form a looped structure that can fit into the annulus ofa heart valve. Each primary loop 700 is connected at each side to asecondary loop 900, and each secondary loop 900 is connected at eachside to a primary loop 700 to form an integral valve prosthesis.

In the looped structure formed by the primary loops 700 and thesecondary loops 900, the proximal portions 708 of the primary loops 700are aligned along a first radial plane, and the proximal portions 908 ofthe secondary loops 900 are aligned along a second radial plane.

In an exemplary embodiment, the loops are connected side-by-side,leaving an amount of spacing between adjacent loops. In anotherexemplary embodiment, the loops are connected side-by-side, leaving noor negligible spacing between adjacent loops.

In an exemplary embodiment, the centers of the mid portions 702 of theprimary loops 700 and the mid portions 902 of the secondary loops 900are aligned along a centerline C.

FIG. 17 illustrates a perspective view of the exemplary loops of FIG. 16where at least a portion of the surface of the primary loops 700 and/orthe secondary loops 900 is covered by a tissue and/or non-tissue graftmaterial 1706 (e.g., PS base woven or braided depending on end useapplications and rate of tissue growth).

In some exemplary embodiments, an anterior portion of the valveprosthesis for deployment in the anterior region of a heart valve isconfigured in the same way as a posterior portion of the valveprosthesis for deployment in the posterior region of a heart valve. Inother exemplary embodiments, the anterior and posterior portions of thevalve prosthesis are configured differently.

In an exemplary embodiment, the anterior and posterior regions of thevalve prosthesis have the same structural configuration. In exemplaryembodiments suitable for application in mitral and tricuspid valves ofthe heart, the valve prosthesis is configured differently in itsanterior region and its posterior region. In exemplary embodimentsillustrated in FIGS. 18A, 18B, 19A and 19B, the anterior and posteriorregions of the valve prosthesis may be configured such that the radialextensions of the proximal and distal portions of the loops areconfigured differently for the anterior and posterior regions. Inexemplary embodiments illustrated in FIGS. 18A, 18B, 19A and 19B, theanterior and posterior regions of the valve prosthesis may be configuredsuch that the primary and/or secondary loops in the anterior regionshave different structural configurations than the primary and/orsecondary loops in the posterior regions.

FIG. 18A illustrates a top view of an exemplary valve prosthesis 1800 inwhich an anterior portion 1802 for deployment in the anterior region ofa heart valve is configured differently from a posterior portion 1804for deployment in the posterior region of a heart valve. The anteriorportion 1802 includes a series of primary loops 700 as illustrated inFIG. 7 connected side-by-side. The posterior portion 1804 includes aseries of primary loops 600 as illustrated in FIG. 6 connectedside-by-side and a series of secondary loops 800 as illustrated in FIG.8 connected side-by-side. The secondary loops 800 are provided withinand/or attached to the primary loops 600 as illustrated in FIG. 10. Inan exemplary embodiment, the mid portions of the primary loops 600 maybe connected to the mid portions of the adjacent primary loops to form asubstantially circular arrangement (as viewed from the top of the valveprosthesis) to provide uniform support at the valve annulus. In anexemplary embodiment, the mid portions of the secondary loops 800 may beconnected to the mid portions of the adjacent secondary loops to form asubstantially semi-circular arrangement (as viewed from the top of thevalve prosthesis).

In an exemplary embodiment, the primary and/or secondary loops of thevalve prosthesis may include sub-annular loops, drapes, anchors, barbs,etc., in only the posterior portion 1804 for aortic and left outflowtrack and overall anterior prosthesis area protection, while providingclinically relevant fixation. In an exemplary embodiment, a skirted areamay be included only in the posterior portion 1804 with/without primarysub-valvular loops. A skirted area may have a greater diameter (takenfrom the center of the valve annulus) than and may extend radiallyoutwardly from a portion of the looped element below the skirted sectionalong the longitudinal axis L.

FIG. 18B illustrates a top view of the valve prosthesis 1800 of FIG. 18Aas covered with a tissue and/or non-tissue graft material 1806 (e.g., PSbase woven or braided depending on end use applications and rate oftissue growth), in its deployed state.

FIG. 19A illustrates a top view of an exemplary valve prosthesis 1900 inwhich an anterior portion 1902 for deployment in the anterior region ofa heart valve is configured differently from a posterior portion 1904for deployment in the posterior region of a heart valve. The anteriorportion 1902 includes primary loops 700 as illustrated in FIG. 7 andsecondary loops 900 as illustrated in FIG. 9. The primary loops 700 andsecondary loops 900 are connected side-by-side in an alternating manneras illustrated in FIG. 16. The posterior portion 1904 includes primaryloops 600 as illustrated in FIG. 6 and secondary loops 800 asillustrated in FIG. 8. The primary loops 600 and secondary loops 800 areconnected side-by-side in an alternating manner as illustrated in FIG.14. In an exemplary embodiment, the mid portions of the loops 600/800may be connected to the mid portions of the adjacent loops to form asubstantially circular arrangement (as viewed from the top of the valveprosthesis) to provide uniform support at the valve annulus.

FIG. 19B illustrates a top view of the valve prosthesis 1900 of FIG. 19Aas covered with a tissue and/or non-tissue graft material 1906 (e.g., PSbase woven or braided depending on end use applications and rate oftissue growth), in its deployed state.

FIG. 20 illustrates a longitudinal section taken through a mitral valvein which the exemplary valve prosthesis 1900 of FIGS. 19A and 19B isdeployed at the annulus of the mitral valve and where at least a portionof the surface of the prosthesis is covered by a tissue and/ornon-tissue graft material 2002 (e.g., PS base woven or braided dependingon end use applications and rate of tissue growth).

FIG. 21 illustrates a longitudinal section taken through a mitral valvein which the exemplary valve prosthesis 1900 of FIGS. 19A and 19B isdeployed at the annulus of the mitral valve.

FIG. 22 illustrates a longitudinal section taken through the mitralvalve shown in FIGS. 20 and 21 where the valve prosthesis 1900 isprovided with radio-opaque markers 2004. FIG. 22A illustrates alongitudinal section taken through the mitral valve shown in FIGS. 20and 21 where the valve prosthesis 2006 is provided with radio-opaquemarkers 2004.

As illustrated in FIGS. 20-22A, the valve prosthesis 2000 is expandedwhen deployed in a heart valve annulus and is safely and securely heldin place by the combined configuration of the primary and secondaryloops. The spacing between the loop elements and within each loopelement in the valve prosthesis may be configured such that the valveprosthesis is compliant and conforms to the shape and the anatomy of thevalve annulus in a natural manner.

In an exemplary embodiment, at least a portion of the outer surface ofthe primary loops is covered by a tissue and/or non-tissue graftmaterial (e.g., PS base woven or braided depending on end useapplications and rate of tissue growth) to provide a radial seal aroundthe valve prosthesis to prevent paravalvular leaks. The covered portionson the primary loops may be the bottom of the mid portion of the primaryloops. In an exemplary embodiment, at least a portion of the outersurface of the secondary loops is covered by a tissue and/or non-tissuegraft material (e.g., PS base woven or braided depending on end useapplications and rate of tissue growth) to provide a radial seal aroundthe valve prosthesis to prevent paravalvular leaks. The covered portionson the secondary loops may be the bottom portion of the secondary loops.The non-tissue graft material (e.g., PS base woven or braided dependingon end use applications and rate of tissue growth) could be impregnatedwith one or more tissue growth agents in desired areas of the valveprosthesis. This encourages faster tissue growth which, in turn, wouldallow for enhanced fastening of the valve prosthesis to the cardiacanatomy and lower fatigue of the valve prosthesis.

In exemplary embodiments, one or more radio-opaque markers may be placedon the primary and/or secondary loops to facilitate in positioning anddeploying the valve prosthesis by a delivery system. The radio-opaquemarkers may be placed only in the posterior region of the valveprosthesis, only in the anterior region of the valve prosthesis, or inboth the posterior and anterior regions. Exemplary markers may include,but are not limited to, pad printed markers or woven monofilamentmarkers.

FIG. 23 is a side view of a single primary loop 2300 having a proximalportion 2302 ending in a terminal tip 2306 and a distal sub-annularportion 2304 ending in a terminal tip 2308. A valve housing portion 2310may extend below the distal sub-annular portion 2304. In an exemplaryembodiment, multiple primary loops 2300 are aligned with each other andconnected side-by-side in series to form a looped structure that fitsinto a heart valve annulus and that supports the valve prosthesisagainst the annulus of the heart valve. In the looped structure formedby the primary loops 2300, the proximal portions 2302 of the primaryloops 2300 are aligned along a first radial plane, and the distalsub-annular portions 2304 of the primary loops 2300 are aligned along asecond radial plane.

The proximal portion 2302 is curved and extends radially and outwardlyaway from the longitudinal axis L of the valve prosthesis in an arcuatemanner. The tip 2306 of the proximal portion 2302 curves downwardly tosome extent in an exemplary embodiment. The proximal portion 2302 isconfigured to be positioned just above the annular ring of the heartvalve such that the arcuate shape of the proximal portion 2302 providesa fastening mechanism for radial fastening of the valve prosthesis tothe atrium or to an upper portion of the heart valve annulus. Thefastening mechanism also provides an outer radial force against the topof the heart valve annulus which securely attaches the valve prosthesisto the heart valve annulus. In the looped structure formed by multipleprimary loops 2300, the proximal portions 2302 adapt to the shape of theannulus of a heart valve and provide natural coverage and a completeradial seal that eliminates paravalvular leaks. In an exemplaryembodiment, the tip 2306 of the proximal portion 2302 may be adjustableand may include a sharp end, e.g., a barb, to penetrate the valveannulus to further secure the valve prosthesis to the annulus.

The distal sub-annular portion 2304 is curved and extends radially andoutwardly away from the longitudinal axis L of the valve prosthesis inan arcuate manner. The tip 2308 of the distal portion 2304 curvesupwardly to some extent in an exemplary embodiment. The distal portion2304 is configured to be positioned under the valve leaflets such thatthe arcuate shape of the distal portion 2304 provides a fasteningmechanism for radial fastening of the valve prosthesis to the ventriclebelow the valve leaflets. The fastening mechanism also provides an outerradial force against the valve annulus which securely attaches the valveprosthesis to the valve annulus and that provides a radial seal betweenthe outer surface of the valve prosthesis and the annulus of a heartvalve to prevent paravalvular leaks.

In exemplary embodiments, the proximal portions 2302 and/or the distalsub-annular portions 2304 of the primary loops 2300 are flexible, andthe curvature and mushroom shape formed by a looped series of primaryloops 2300 are automatically adjustable due to the flexible nature ofthe proximal and/or distal portions. This adjustability allows foradjusting the shape of the annulus formed by the valve prosthesis. Thisallows an exemplary valve prosthesis to conform to the annular shape ofany heart valve. That is, a looped series of connected primary loops maybe placed in any heart valve annulus, and the compliant nature of theloops will allow the prosthesis to conform to the particular structureof the valve annulus. As such, one size of the valve prosthesis may fitany annulus and this may reduce the overall profile for a deliverydevice and may, consequently, reduce the access puncture point andimprove deliverability and tactile feeling of the valve prosthesis. Inaddition, a clinically relevant smaller valve annulus size may haveimproved shelf life.

FIG. 31 illustrates a longitudinal sectional taken through a heart 3100in which an exemplary valve prosthesis 3102 formed by a looped series ofthe primary loops 2300 (illustrated in FIG. 23) is disposed in theannulus of the mitral valve.

FIG. 24 is a side view of a single primary loop 2400 having a proximalportion 2402 ending in a terminal tip 2408 and a distal sub-annularportion 2404 ending in a terminal tip 2410. An exemplary valveprosthesis formed by the loops of FIG. 24 includes a skirted section2406 that has a larger diameter than the valve housing portion 2310illustrated in FIG. 23, provided distal to the primary loops 2400. Thatis, the skirted section 2406 extending downward from the portions 2402and 2404 along the longitudinal axis L has a greater diameter (takenfrom the center of the valve annulus) than and extends radiallyoutwardly from a portion below the skirted section along thelongitudinal axis L.

FIG. 25 is a side view of a single primary loop 2500 that is an invertedversion of the exemplary primary loop 2300 of FIG. 23. The primary loop2500 has a proximal portion 2502 ending in a terminal tip 2506 and adistal portion 2504 ending in a terminal tip 2508. A valve housingportion 2510 may extend above the proximal portion 2502.

The proximal portion 2502 is curved and extends radially and outwardlyaway from the longitudinal axis L of the valve prosthesis in an arcuatemanner.

The tip 2506 of the proximal portion 2502 curves downwardly to someextent in an exemplary embodiment. The proximal portion 2502 isconfigured to be positioned just above the annular ring of the heartvalve such that the arcuate shape of the proximal portion 2502 providesa fastening mechanism for radial fastening of the valve prosthesis tothe atrium or to an upper portion of the heart valve annulus. Thefastening mechanism also provides an outer radial force against the topof the heart valve annulus which securely attaches the valve prosthesisto the heart valve annulus. In an exemplary embodiment, the tip 2506 ofthe proximal portion 2502 may be adjustable and may include a sharp end,e.g., a barb, to penetrate the valve annulus to further secure the valveprosthesis to the annulus.

The distal portion 2504 is curved and extends radially and outwardlyaway from the longitudinal axis L of the valve prosthesis in an arcuatemanner. The tip 2508 of the distal portion 2504 curves upwardly to someextent in an exemplary embodiment. The distal portion 2504 is configuredto be positioned under the valve leaflets such that the arcuate shape ofthe distal portion 2504 provides a fastening mechanism for radialfastening of the valve prosthesis to the ventricle below the valveleaflets. The fastening mechanism also provides an outer radial forceagainst the valve annulus which securely attaches the valve prosthesisto the valve annulus and that provides a radial seal between the outersurface of the valve prosthesis and the annulus of a heart valve toprevent paravalvular leaks. In an exemplary embodiment, the tip 2508 ofthe proximal portion 2504 may be adjustable and may include a sharp end,e.g., a barb, to penetrate the valve annulus to further secure the valveprosthesis to the annulus.

In exemplary embodiments, the proximal portions 2502 and/or the distalsub-annular portions 2504 of the primary loops 2500 are flexible, andthe curvature and mushroom shape formed by a looped series of primaryloops 2500 are automatically adjustable due to the flexible nature ofthe proximal and/or distal portions. This adjustability allows foradjusting the shape of the annulus formed by the valve prosthesis. Thisallows an exemplary valve prosthesis to conform to the annular shape ofany heart valve. That is, a looped series of connected primary loops maybe placed in any heart valve annulus, and the compliant nature of theloops will allow the prosthesis to conform to the particular structureof the valve annulus. As such, one size of the valve prosthesis may fitany annulus and this may reduce the overall profile for a deliverydevice and may, consequently, reduce the access puncture point andimprove deliverability and tactile feeling of the valve prosthesis. Inaddition, a clinically relevant smaller valve annulus size may haveimproved shelf life.

FIG. 33 illustrates a longitudinal sectional taken through a heart 3300in which an exemplary valve prosthesis 3302 formed by a looped series ofthe primary loops 2500 (illustrated in FIG. 25) is disposed in theannulus of the mitral valve.

FIG. 26 is a side view of a single pairing 2600 of a primary loop 2602and a secondary loop 2604. The primary loop 2602 has a proximal portion2606 ending in a terminal tip 2608 and a distal sub-annular portion 2610ending in a terminal tip 2612. The secondary loop 2604 has a proximalportion 2614 ending in a terminal tip 2616. A valve housing portion 2618may extend below the distal sub-annular portion 2610.

In an exemplary embodiment, multiple primary loops 2602 are aligned witheach other and connected side-by-side in series to form a loopedstructure that fits into the heart valve annulus and that supports thevalve prosthesis against the annulus of the heart valve. Multiplesecondary loops 2604 are aligned with each other and connectedside-by-side in series to form a looped structure that fits into theheart valve annulus and that supports the valve prosthesis against theannulus of the heart valve. The secondary loops 2604 may be providedwithin the primary loops 2602 in an exemplary embodiment.

In the looped structure formed by the primary loops 2602 and thesecondary loops 2604, the proximal portions 2606 of the primary loops2602 are aligned along a first radial plane, the proximal portions 2614of the secondary loops 2604 are aligned along a second radial planebelow the first radial plane, and the distal sub-annular portions 2610of the primary loops 2602 are aligned along a third radial plane belowthe first and second radial planes.

The proximal portion 2606 of the primary loop 2602 and the proximalportion 2614 of the secondary loop 2604 are curved and extend radiallyand outwardly away from the longitudinal axis L of the valve prosthesisin an arcuate manner. The tip 2608 of the proximal portion 2606 of theprimary loop 2602 and the tip 2616 of the proximal portion 2614 of thesecondary loop 2604 curve downwardly to some extent in an exemplaryembodiment. The proximal portion 2606 of the primary loop 2602 and theproximal portion 2614 of the secondary lop 2604 are configured to bepositioned just above the annular ring of the heart valve such that thearcuate shape of the proximal portions provides a fastening mechanismfor radial fastening of the valve prosthesis to the atrium or to anupper portion of the heart valve annulus. The fastening mechanism alsoprovides an outer radial force against the top of the heart valveannulus which securely attaches the valve prosthesis to the heart valveannulus.

The distal sub-annular portion 2610 of the primary loop 2602 is curvedand extends radially and outwardly away from the longitudinal axis L ofthe valve prosthesis in an arcuate manner. The tip 2612 of the distalportion 2610 curves upwardly to some extent in an exemplary embodiment.The distal portion 2610 is configured to be positioned under the valveleaflets such that the arcuate shape of the distal portion 2610 providesa fastening mechanism for radial fastening of the valve prosthesis tothe ventricle below the valve leaflets. The fastening mechanism alsoprovides an outer radial force against the valve annulus which securelyattaches the valve prosthesis to the valve annulus and that provides aradial seal between the outer surface of the valve prosthesis and theannulus of a heart valve to prevent paravalvular leaks.

FIG. 32 illustrates a longitudinal sectional taken through a heart 3200in which an exemplary valve prosthesis 3202 formed by a looped series ofthe primary loops 2602 (illustrated in FIG. 26) and a looped series ofthe secondary loops 2604 (illustrated in FIG. 26) is disposed in theannulus of the mitral valve.

FIG. 27 is a side view of a single pairing 2700 of a primary loop 2702and a secondary loop 2704. The primary loop 2702 has a proximal portion2706 ending in a terminal tip 2708 and a distal sub-annular portion 2708ending in a terminal tip 2712. The secondary loop 2704 has a proximalportion 2714 ending in a terminal tip 2716. An exemplary valveprosthesis formed by the loops of FIG. 27 includes a skirted section2718, that has a larger diameter than the embodiment illustrated in FIG.26, provided distal to the primary and secondary loops. That is, theskirted section 2718 extending downward from the portion 2702 along thelongitudinal axis L has a greater diameter (taken from the center of thevalve annulus) than and extends radially outwardly from a portion belowthe skirted section along the longitudinal axis L.

FIG. 28 is a side view of a single pairing 2800 of a primary loop 2802and a secondary loop 2804 that is an inverted version of the exemplaryprimary loop 2600 of FIG. 26. The primary loop 2802 has a proximalportion 2806 ending in a terminal tip 2808 and a distal sub-annularportion 2810 ending in a terminal tip 2812. The secondary loop 2804 hasa distal portion 2814 ending in a terminal tip 2816.

The proximal portion 2806 of the primary loop 2802 is curved and extendsradially and outwardly away from the longitudinal axis L of the valveprosthesis in an arcuate manner. The tip 2808 of the proximal portion2806 of the primary loop 2806 curves downwardly to some extent in anexemplary embodiment. The proximal portion 2806 of the primary loop 2802is configured to be positioned just above the annular ring of the heartvalve such that the arcuate shape of the proximal portions provides afastening mechanism for radial fastening of the valve prosthesis to theatrium or to an upper portion of the heart valve annulus. The fasteningmechanism also provides an outer radial force against the top of theheart valve annulus which securely attaches the valve prosthesis to theheart valve annulus.

The distal sub-annular portion 2810 of the primary loop 2802 and thedistal portion 2814 of the secondary loop 2804 are curved and extendradially and outwardly away from the longitudinal axis L of the valveprosthesis in an arcuate manner. The tip 2812 of the distal portion 2810of the primary loop 2802 and the tip 2816 of the distal portion 2814 ofthe secondary loop 2804 curve upwardly to some extent in an exemplaryembodiment. The distal portions 2810 and 2814 are configured to bepositioned under the valve leaflets such that the arcuate shape of thedistal portions provides a fastening mechanism for radial fastening ofthe valve prosthesis to the ventricle below the valve leaflets. Thefastening mechanism also provides an outer radial force against thevalve annulus which securely attaches the valve prosthesis to the valveannulus and that provides a radial seal between the outer surface of thevalve prosthesis and the annulus of a heart valve to preventparavalvular leaks.

FIG. 34 illustrates a longitudinal sectional taken through a heart 3400in which an exemplary valve prosthesis 3402 formed by a looped series ofthe primary loops 2800 (illustrated in FIG. 28) is disposed in theannulus of the mitral valve.

FIG. 29 is a side view of a loop element 2900 for a valve prosthesishaving a proximal skirted region 2902 that extends above the annularring and that fastens the valve prosthesis to the atrial wall, and aprimary sub-annular loop 2904 that extends at or below the valveleaflets in the annular ring and that fastens the valve prosthesis tothe annular wall or to the ventricle.

FIG. 35 illustrates a longitudinal sectional taken through a heart 3500in which an exemplary valve prosthesis 3502 formed by a looped series ofthe loop elements 2900 (illustrated in FIG. 29) is disposed in theannulus of the mitral valve.

FIG. 30 is a side view of a loop element 3000 for a valve prosthesishaving a proximal skirted region 3002 that extends above the annularring and that fastens the valve prosthesis to the atrial wall, a primarysub-annular loop 3006 that extends at or below the valve leaflets in theannular ring and that fastens the valve prosthesis to the annular wallor to the ventricle, and a secondary sub-annular loop 3004 that extendsat or below the valve leaflets in the annular ring and that fastens thevalve prosthesis to the annular wall or to the ventricle. The secondaryloop 3004 may be nested within the primary loop 3002 and may be disposedproximally above the primary loop 3002.

FIG. 36 illustrates a longitudinal sectional taken through a heart 3600in which an exemplary valve prosthesis 3602 formed by a looped series ofthe loop elements 3000 (illustrated in FIG. 30) is disposed in theannulus of the mitral valve. Any portion of the surfaces of the loops ofFIGS. 23-30 may be covered with a tissue and/or non-tissue graftmaterial (e.g., PS base woven or braided depending on end useapplications and rate of tissue growth). The loops may include fasteningmechanisms including, but not limited to, barbs, anchors, fixations,spacers, drapes, etc.

FIG. 37A illustrates a top view of an exemplary valve prosthesis formedof the exemplary loops of FIG. 23 or FIG. 26, with one or more primaryloops 4202 covered with a material layer 4204. FIG. 37B illustrates atop view of the exemplary valve prosthesis of FIG. 37A as deployed in aheart valve annulus. In some exemplary embodiments, the material mayextend over and across a gap formed between the loops. In some exemplaryembodiments, the material may extend over and across the loops, but notthe gaps between the loops.

FIG. 37C illustrates a bottom view of an exemplary valve prosthesisformed of the exemplary loops of FIG. 23, showing distal portions ofprimary loops 4202 deployed under the heart valve annulus. In anexemplary embodiment, areas of the distal portion of the primary loops4202 may be provided with a material layer 4204. In some exemplaryembodiments, the primary loops may push the native annulus aside andreach into the top portions of the valve leaflets under the annulus. Inthe exemplary embodiment shown in FIG. 37C, primary loops are providedboth in the posterior and anterior regions.

FIG. 38 illustrates an exemplary valve prosthesis formed of theexemplary loops of FIG. 23 used for replacing a mitral valve 4312 at amitral annulus 4308. The prosthesis may form a new annulus 4306. Thevalve prosthesis is formed of the exemplary loops attached in a circulararrangement. Each of the primary loops may include a proximal portion4302 (including, for example, one or more fixation or anchoringcomponents 4310), a distal sub-annular portion 4314 (including, forexample, one or more fixation or anchoring components), and a valvehousing portion 4304.

FIG. 39 illustrates a top view of an exemplary valve prosthesis of FIG.26 deployed in a heart valve annulus showing proximal portions ofprimary loops 4402 and secondary loops 4404 above the native annulus.

FIG. 40 illustrates a distal side view of an exemplary valve prosthesisshowing exemplary primary loops having a distal portion 4502 and aproximal portion 4504, and secondary loops having a proximal portion4506.

FIG. 41 illustrates an exemplary valve prosthesis formed of theexemplary loops of FIG. 26 used in replacing a mitral valve 4612 at amitral annulus 4608. The prosthesis may form a new annulus 4606. Thevalve prosthesis is formed of the exemplary loops attached in a circulararrangement. Each of the primary loops may include a proximal portion4602 (including, for example, one or more fixation or anchoringcomponents 4610), a distal sub-annular portion 4614 (including, forexample, one or more fixation or anchoring components), and a valvehousing portion 4604.

FIG. 42 illustrates an exemplary valve prosthesis formed of exemplaryloops having a skirted mid and distal portion used in replacing a mitralvalve 4712 at a mitral annulus 4708. The prosthesis may form a newannulus 4706. The valve prosthesis is formed of exemplary loops attachedin a circular arrangement. Each of the primary loops may include aproximal portion 4702 (including, for example, one or more fixation oranchoring components 4710), a distal sub-annular portion 4714(including,for example, one or more fixation or anchoring components), and a valvehousing portion 4704. Each loop may have a skirted configuration 4716 atthe valve housing portion 4704.

In an exemplary embodiment, an exemplary valve prosthesis may bedeployed by a catheter and may self-expandable when deployed at a heartvalve annulus. In another exemplary embodiment, the valve prosthesis maybe deployed by a catheter and may be expandable by a balloon whendeployed at a heart valve annulus.

FIG. 43 illustrates an exemplary delivery device 3700 for delivering avalve prosthesis to a heart valve annulus. The device 3700 includes alongitudinal body 3702 in which the valve prosthesis may be disposed.The valve prosthesis may be connected at a proximal end close to theoperator to a projection mechanism 3703 that may be actuated to projectthe valve prosthesis out of the body through a lumen 3704 provided atthe front end of the body. The projecting mechanism 3703 may selectivelyactuate and deploy the proximal primary loops, the proximal secondaryloops and the sub-annular loops of the valve prosthesis. The device 3700may include one or more mechanisms 3706 and 3708 for actuating theprojecting mechanism 3703. The device 3700 may allow the valveprosthesis to be retrieved from the patient's body prior to its fulldeployment and release.

In exemplary embodiments, one or more radio-opaque markers may be placedon the delivery device to facilitate in positioning and deploying avalve prosthesis by the delivery device. The markers may also enhancephysician feedback and a tactile feeling. Exemplary markers may include,but are not limited to, radial markers, individual markers, pad printedmarkers and/or woven monofilament markers.

Before, during and after delivery, imaging and annular mapping of theannulus of the heart valve and its surrounding cardiac anatomy isperformed. Considerations of patient safety and the device size maydrive the access point on the patient's body that is selected fordelivering the valve prosthesis. In an exemplary method for delivering amitral valve replacement, an exemplary delivery device is inserted overa guide wire into a prepositioned introducer sheath into the femoralvein, and eventually through the patent foramen ovale wall above thevalve annulus. The device may be advanced to the left ventricle towardthe bottom of its apex. Before proceeding, imaging, e.g., fluoroscopic,may be performed to image the valve annulus, the surrounding anatomy andthe device in relation to the annulus and the anatomy. The device may beradio-opaque and have markers. In another exemplary method, the deliverydevice may be inserted percutaneously or by off-pump thorocodomy bydirect access to the apex, chest and jugular areas of the patient.

FIG. 44 illustrates an exemplary valve prosthesis 3800 that is anchoredby one or more holding strings 3802 that connect to an anchoringmechanism 3804 at the bottom of the ventricular apex 3806. Thisconfiguration allows the valve prosthesis to be anchored to the bottomof the apex. If the prosthesis is deployed from the atrium (in an apicalapproach), the primary loops are first deployed and the sub-annularloops are subsequently deployed. Prior to the delivery device exitingthe apex, the anchoring mechanism 3804 is put in place such that thevalve prosthesis 3800 is connected to the anchoring mechanism 3804through the strings 3802. If the prosthesis is deployed in a femoralapproach, the anchoring mechanism 3804 is first put in place at the apex3806, the sub-annular loops are deployed, and subsequently the primaryloops are deployed.

In a minimally invasive method illustrated in FIGS. 47A-47D, anexemplary delivery device 4100 may have a left ventricular transapicalaccess. As illustrated in FIG. 47A, an apical wire 4102 may be placedthrough the mitral valve 4104. As illustrated in FIG. 47B, the deliverydevice 4100 may be advanced over the wire 4102 through the mitral valve4104 to the left atrium 4106. Before proceeding, imaging, e.g.,fluoroscopic, may be performed to image the valve annulus at the mitralvalve 4104, the surrounding anatomy and the device 4100 in relation tothe annulus and the anatomy. The device 4100 may be radio-opaque andhave markers. As illustrated in FIGS. 47C-47E, the proximal primaryloops, the proximal secondary loops and the sub-annular loops of thevalve prosthesis, respectively, may be deployed using one or moreprojection mechanisms in the delivery device.

FIG. 45 illustrates an exemplary valve prosthesis 3900 that is anchoredby one or more holding strings 3902 that connect to an anchoringmechanism 3904 at a ventricular septal wall 3906.

FIG. 46 illustrates an exemplary valve prosthesis 4000 that is deliveredby a retrograde catheter system 4002 through the aorta. The valveprosthesis 4000 may be anchored to the ventricle using one or moreanchors. The example of FIG. 46 shows two exemplary anchors 4004 and4006 deployed at either end of the posterior region of the mitral valveto anchor the valve prosthesis 4000 in the annulus.

Further Delivery Systems and Prostheses

The prostheses illustrated above can be installed in place as disclosedabove and additionally by applying clips and other fasteners to keepthem in place.

In accordance with further aspects of the disclosure, systems andrelated methods are provided for installing prostheses such as thosedisclosed above by way of a guide rail system. Such systems can be usedfor repair of the mitral and tricuspid valves as set forth above, buthave equal applicability in other applications. Such systems areparticularly advantageous for use in other locations in the lumenalsystems of the body for placement of prostheses and the like, as setforth in further detail below.

In accordance with the illustrative embodiments concerning placement ofa prosthesis in the mitral and tricuspid valves, it is preferred toperform proper imaging and annular mapping of the mitral valve annulusand adjacent anatomies before, during and after the prosthesis placementprocedure. The procedures described herein concerning coronary valvesmay be performed by way of a minimally invasive incision and suitableaccess port into the thoracic cavity, or may be performed percutaneouslyvia femoral or jugular access. Before proceeding, all vital signs shouldbe checked, then detailed ICE or 3D echo and fluoroscopic imaging of thevalve annulus and surrounding anatomy and its relation to the deliverysystem components and prosthesis should be performed. The deliverysystem as well as the prosthesis is preferably provided with appropriateradiopaque markers to facilitate placement as described herein.

For purposes of illustration, and not limitation, FIG. 48 illustrates afirst step of an exemplary method for implanting a prosthesis in themitral valve of a patient. The technique begins with introducing anintroducer sheath 4820 of delivery system 4800 replacing a mitral valve1000 having leaflets 1002, 1004. The introducer sheath 4820 isintroduced into the left ventricle through the bottom of the ventricleand advanced and directed toward the ventricular side of the mitralannulus. It will be appreciated that the system can be modified forpercutaneous delivery and that the present depicted method is only forpurposes of illustration. Disposed within the delivery sheath 4820 isthe main delivery system 4830 preferably having an articulable distalend as well as one or more radiopaque markers, such as marker bands. Themain delivery system 4830 is then advanced and positioned behind theposterior mitral leaflet 1004 just under the annulus to the posteriormitral commissure. The mitral commissures are difficult to detect duringsurgery, and can be identified, for example, by using two anatomiclandmarks: the axis of corresponding papillary muscles and thecommissural chordate. Several millimeters of valvular tissue separatesthe free edge of commissures from the annulus. Distal end 4832 ofdelivery catheter 4830 is thus articulated to the posterior commissure.Next, an articulable lance, or poker 4850 is advanced through a distalend of a puncture catheter 4840, which is in turn housed within catheter4830, into the posterior mitral commissure and into the left atrium toprovide a path and guide rail for passing the puncture catheter 4840through the posterior commissure and into the atrium. The puncturecatheter 4840 may be of a peelable configuration, if desired. Afterfurther imaging to ensure that the procedure has been performedproperly, the lance 4850 can be withdrawn back into the puncturecatheter 4840, leaving catheter 4840 in path to act as a conduit forplacement of further components of the system. The system 4800 can beused in like manner to provide passage for the puncture catheter 4840through the anterior mitral commissure.

Once the puncture catheter is in place, it is possible to next place aguide rail in place that will anchor and bear against either the atrialor ventricular side of the mitral annulus at the anterior and posteriorcommissures. If it is desired to place an anchored guide rail whereinthe anchor bears against the ventricular side of the valve annulus, aspecial guide wire/guide member as depicted in FIG. 49 can be used.

For purposes of illustration, and not limitation, guide member 4900includes a first end 4910 having an anchor disposed thereon. Anchor 4910is preferably a compliant foldable material, such as PTFE or PS fabricor ePTFE material (as described, for example, in U.S. Pat. No. 6,436,135to Goldfarb, incorporated by reference herein in its entirety). Anchor4910 preferably includes radiopaque material. As illustrated, anchor4910 is attached to a tether 4920, such as of PTFE or other suitablematerial. Tether 4920 is preferably modified to include radiopaquematerial, and includes a first end 4922 attached to anchor 4910, and asecond end 4924 attached to a first, distal end 4932 of a guidewire/guide member 4930. If desired, a plurality of locks or crimps 4940can be provided on the tether 4920 to bear against the ventricular sideof the annulus and hold anchor 4910 in place against the ventricularside of the annulus, described in further detail below. Guide member4930 is preferably pre-attached to tether 4920, and preferably has adiameter of 0.35 inches or larger. A proximal docking station 4950 canbe provided at a proximal end of the guide member for attachment to afurther member that can be used to pull on the guide member 4930 toadvance tether 4920 until anchor 4910 is urged against the mitralannulus. FIG. 50 illustrates a modified guide member 5030 that can beused for placement of an anchor 4910 against the atrial side of themitral annulus, and FIG. 51 illustrates a tether 5120 having an anchor5110, locks 5140 and docking station or connector 5150, whereinconnector/docking station 5150 is adapted and configured to connect withdistal docking station 5050 a of guide 5030, whereas proximal dockingstation 5050 b fulfills a function similar to docking station 4950. Theuse of the embodiments depicted in FIGS. 49-51 are described in furtherdetail below.

FIGS. 52A, 53A, 54A, 55A and 56A illustrate a first exemplary method andsystem for disposing a pair of guide rails in the mitral annulus,wherein anchors are disposed on the underside (ventricular side) of theannulus of the mitral valve by way of the left ventricle using guidemember 4900.

As depicted in FIG. 52A, the puncture catheter 4840 is withdrawn backinto the delivery system 4800, and the proximal end 4950 of the specialguide wire of the guide member 4900 is advanced through the deliverysystem, through the incision made by the puncture catheter 4840, andsteered toward and through the mitral valve 1000 into the leftventricle. As depicted in FIG. 53A, a forceps, grasper or other device5300, preferably with a radiopaque marker proximate its distal end 5302,is advanced through the delivery system 4800 and into the left ventricleto capture the end 4950 of the guide 4900. As illustrated in FIG. 54A,the proximal end 4950 of guide 4900 is withdrawn into the introducersheath 4820 of delivery device 4800. Guidewire section 4930 of guide4900 is then drawn fully through the commissure of the annulus of themitral valve. As depicted in FIG. 55A, as the guidewire section 4930exits the introducer sheath 4820, the tether 4920 is withdrawn from thesheath 4820, and passes through the annulus until the anchor 4910 isurged against the ventricular side of the mitral annulus. The processcan then be repeated at the location of the anterior commissure, asdepicted in FIG. 56A. At this point, locks/crimps 4940 can be advancedto the atrial side of the annulus and secured in place, resulting in thetethers 4920 being directed through the mitral valve and out of theheart to act as placement guides for a prosthesis.

FIGS. 52B, 53B, 54B, 55B and 56B illustrate a second exemplary methodand system for disposing a pair of guide rails in the mitral annulus,wherein anchors are disposed on the upper side (atrial side) of theannulus of the mitral valve by way of the left ventricle using guidemember 5000 that includes the combination of guide 5030 and tether 5120.

As depicted in FIG. 52B, the puncture catheter 4840 is withdrawn backinto the delivery system 4800, and the proximal end 5050 a of thespecial guide wire of the guide member 5000 is advanced through thedelivery system, through the incision made by the puncture catheter4840, and steered toward and through the mitral valve 1000 into the leftventricle. As depicted in FIG. 53B, a forceps, grasper or other device5300, preferably with a radiopaque marker proximate its distal end 5302,is advanced through the delivery system 4800 and into the left ventricleto capture the end 5050 a of the guide 5030. As illustrated in FIG. 54B,the proximal end 5050 a of guide 4900 is withdrawn into the introducersheath 4820 of delivery device 4800. Guidewire section 5030 of guide5000 is then drawn fully through the commissure of the annulus of themitral valve. As depicted in FIG. 55B, as the guidewire section 5030exits the introducer sheath 4820, the tether 5020 is withdrawn from thesheath 4820, and passes through the annulus until the anchor 5010 isurged against the atrial side of the mitral annulus. The process canthen be repeated at the location of the anterior commissure, as depictedin FIG. 56B. At this point, locks/crimps 5040 can be advanced to theventricular side of the annulus and secured in place, resulting in thetethers 5020 being directed through the mitral valve and out of theheart to act as placement guides for a prosthesis.

A variety of devices can be used for locks 4940, 5040. For example,crimpable clips can be used, as well as buckles including a plate withtwo or more holes therethrough wherein the tether 4920, 5020 is routedthrough a first hole in the plate from a first side of the plate to thesecond side of the plate, and then through a second hole from the secondside of the plate to the first side of the plate. The tether can then beheld stationary with respect to the plate/clip by frictional forcesand/or by folding the plate onto itself with forceps to crimp it.Moreover, if desired, the portion of tether 4920, 5020 proximate anchor4910, 5010 can be provided with ratcheting teeth that engagecomplementary teeth or a slit in the locks 4940, 5040 such that theratchet engagement maintains the position of the lock 4940, 5040. Itwill be appreciated that a variety of other locks can be used, and thatthese examples are merely illustrative.

Portions of delivery system 4800 (e.g., 4820, 4830, 4840) as well as theprosthesis delivery systems disclosed herein may be made in a variety ofways and from a variety of materials, such as metal, plastic andcomposite materials. Metal tubes such as stainless steel hypotubes canbe used for one or more portions of delivery system 4800 for enhancedpushability alone or in combination with other suitable materials. Ifmetal tubular components are used to make portions of system 4800, theyare preferably coated with a lubricious material such as PTFE, otherhydrophobic materials or hydrophilic materials. Multilayered polymerictubes can also be used to form portions of system 4800 that can beformed by coextrusion, dipping processes, or by shrinking tubing layersover one another over a mandrel. Moreover, polymeric tubular members canalso be formed by charging a mandrel with static electricity, applyingplastic in powder or granular form to the mandrel to form a layer ofplastic over the mandrel, and by heating the mandrel to cause theparticles to fuse.

If desired, one or more of components 4820, 4830, 4840 as well as theprosthesis delivery systems disclosed herein can include a multi-layeredcoextrusion, such as those described in U.S. Pat. No. 6,464,683 toSamuelson or U.S. Pat. No. 5,538,510 to Fontirroche. Each of theaforementioned patents is incorporated by reference herein in itsentirety. Any surface of various components of the catheters describedherein or portions thereof can be provided with one or more suitablelubricious coatings to facilitate procedures by reduction of frictionalforces. Such coatings can include, for example, hydrophobic materialssuch as PolyTetraFluoroEthylene (“PTFE”) or silicone oil, or hydrophiliccoatings such as Polyvinyl Pyrrolidone (“PVP”). Other coatings are alsopossible, including, echogenic materials, radiopaque materials andhydrogels, for example. Multilayered polymeric tubes can also be usedthat include metallic or nonmetallic braiding within or between layersof the tube. A carbon tube can also be used, as well as fiber-reinforcedresin materials.

In accordance with further aspects, any portion of delivery system 4800(particularly portions 4820, 4830, 4840) as well as the prosthesisdelivery systems disclosed herein can be provided with a decreasingstiffness along its length from a proximal portion to a distal portion.As will be further appreciated by those of skill in the art, introducersheath 4820 or delivery catheter 4830 can also include a multiple-lumenextrusion including two, three, four, or more lumens along part of orsubstantially the entire length thereof. Moreover, stiffening memberssuch as stiffening wires can be used at various locations along portionsof components 4820, 4830, 4840 to provide stiffness transitions betweenrelatively stiffer regions and less stiff regions, as well as proximateregions of stress concentration. In accordance with one embodiment, aguidewire lumen 118 is provided along substantially the entire length ofelongate body 110 as with typical over the wire (“OTW”) catheters. Inaccordance with another embodiment, a guidewire lumen (not shown) isprovided along a distal length of components 4820, 4830 and/or 4840 topermit use of such components as rapid exchange “RX”) catheters. Thiscan be useful both when accessing the heart via the thoracic cavity, aswell as when accessing the heart via the aortic arch.

The docking station(s) (e.g., 4950, 5050 a, 5050 b) may include varioustypes of connectors, such as snap fit, threaded and the like. Suitableconnectors can be found, for example, in U.S. Pat. No. 4,827,941, U.S.Pat. No. 5,617,875, U.S. Pat. No. 4,917,103, U.S. Pat. No. 4,922,923,U.S. Pat. No. 5,031,636 and U.S. Reissue Pat. No. 34,466. Each of thesepatents is incorporated by reference herein in its entirety. An actuator(not shown) may be used to produce relative movement between the variouscomponents of the delivery system 4800, as well as other deliverysystems described above and below for delivering and deploying aprosthesis. For example, a relatively simple push-pull actuator may beprovided. Moreover, it is also possible to use other actuators as areknown in the art, such as threaded rotating actuators as described inU.S. Pat. No. 6,488,694 to Lau and U.S. Pat. No. 5,906,619 to Olson,each of which is incorporated by reference herein in its entirety.

It will be further appreciated that the tethers need not be installed atthe commissures of the mitral annulus, but instead or in addition may beinstalled at any portion of the mitral annulus. Thus, while two tethersare depicted, any desired number, (e.g., three, four, five, etc.) may beinstalled. It will be further appreciated that a like procedure can beperformed at the tricuspid valve or other locations within the luminalsystems of a patient, discussed in further detail below.

In further accordance with the disclosure, once one or more tethers, orrails, are in place, a prosthesis can be advanced to a locationproximate the tether anchor, and secured in place.

For purposes of illustration, and not limitation, as embodied herein andas depicted in FIGS. 57-63, methods and systems are provided forinstallation of various prostheses proximate the mitral valve of apatient. While only procedures with respect to rails anchored on theventricular side of the mitral annulus for purposes of brevity, it willbe appreciated that such procedures are equally applicable

With reference to FIG. 57A, a prosthesis 5700 is provided having a firstbottom circumferential end 5712, a second top circumferential end 5714and defining a general cylindrical body 5730 between the ends. The bodymay be straight or tapered, and may be flared as desired. Loops 5702 areprovided defining the structure of the prosthesis can serve as a conduitfor passage of the tethers or rails 4920, 5020. Preferably, channels orconduits 5710 are provided on prosthesis for specifically receiving thetethers or rails 4920, 5020. While a full prosthesis that occupies thefull mitral orifice is illustrated in FIGS. 57A-57B, it is similarlypossible to provide a prosthesis 5780 that occupies only a portion ofthe valve upon installation as depicted in FIG. 57(C). As depicted,prosthesis 5780 has a bottom arcuate edge 5782 upon deployment, an upperarcuate edge 5784 upon deployment, and defines a generally arcuate body5785 upon deployment depicted as including a series of structural loops5786 connected to a curved planar membrane 5785, and depicted asincluding a plurality of conduits 5710 for receiving guide rails. Thus,in the case of a mitral valve, one or two half-valves can be installedthat sits on one of the leaflets, while in the case of tricuspid valveprocedures, a single full prosthesis can be installed, or one or morepartial prostheses that occupy one or two thirds of the valve or theentire valve. Thus, in the case of the tricuspid valve, a single implantcan be used to replace the entire valve, one third of the valve or twothirds of the valve. Similarly, two prostheses can be used to replacethe entire valve, wherein one prosthesis is used to replace one of theleaflets, and the remaining two leaflets are replaced by way of a secondprosthesis. In any event, the prosthesis can be made of self expandingmaterial (e.g., NiTi alloys), conventional alloys (e.g., stainlesssteels) or biodegradable materials. One or more radiopaque markers ispreferably provided along the length and/or disposed about thecircumference of the valve to facilitate axial and rotational alignmentof the prosthesis. It will be further appreciated that a full or partialprosthesis can be provided in accordance with any embodiment describedherein that contains no valve at all but that instead provides a fullyor partial open channel (illustrated, for example, in FIG. 22) to simplyprovide patency or to serve as a platform for attaching a secondimplantable device. Thus, the prosthesis 5700 can be used to provide aplatform for installing any desired replacement valve, whether the valveis synthetic and/or made from living tissue. It will be furtherappreciated that the prosthesis 5700 can be provided with a valve(and/or other portions, as desired) made from living tissue. As furtherillustrated, two rails are used for placement of the prostheses, but itwill be appreciated that any number of rails can be used at any desiredlocation in the valve annulus, or elsewhere in the anatomy, to deliverand install the prosthesis.

In use, as depicted in FIG. 58A, prosthesis 5700 is disposed overrails/tethers 4920 and advanced toward the mitral orifice along therails/tethers 4920 as depicted in FIG. 58B. Once initially installed,the prosthesis can be held in place using a variety of techniques asdescribed with respect to anchoring tethers 4920, 5020. FIGS. 59A-59Billustrate a similar installation of half prosthesis 5780. After initialinstallation, the patient's heart's performance can be monitored and thepositioning of the prosthesis can be fine tuned. Once the prosthesis isin its final position, the prosthesis can be locked in placepermanently. Clips or locks can be used, moreover, the conduits 5710 canbe deformable and can be crushed over rails/tethers 4920, 5020 to lockthe prosthesis 5700 in place and tethers removed in FIG. 60A for a fullprosthesis and 60B for a partial prosthesis.

In accordance with further embodiments, the disclosure provides aprostheses having one or more tethers attached thereto for installingthe prosthesis and techniques for installing the same. In particular,methods are provided including anchoring a rail at a target anatomicallocation within a patient's lumenal system, advancing a prosthesishaving a tether over the rail, and attaching the rail to the tether tosecure the prosthesis in place.

For purposes of illustration, and not limitation, as embodied herein andas depicted in FIG. 61(A), a full mitral valve prosthesis 6100 isprovided having a lower circumferential edge 6102 and an uppercircumferential edge 6104 defining a generally cylindrical bodytherebetween defined by a plurality of loops 6108 connected to amembrane 6106. The body may be tapered along its length and/or haveflared ends, as desired. The prosthesis 6100 further includes one ormore tethers 6112. Prosthesis is installed in the same manner asprosthesis 5700 insofar as it is advanced along rails 4920 via conduits6110 to its final location. FIG. 61A further depicts the accessdirection in dotted lines in the case of atrial percutaneous delivery.

Similarly, FIG. 61B depicts a partial (e.g., half) prosthesis 6180installation in a mitral annulus, wherein the prosthesis includes abottom arcuate edge 6182 upon deployment, an upper arcuate edge 6184upon deployment, and defines a generally arcuate body upon deploymentdepicted as including a series of structural loops 6186 connected to acurved planar membrane 6185, and depicted as including a plurality ofconduits 6110 for receiving guide rails as well as one or more tethers6172. FIG. 61B further depicts the access direction in dotted lines inthe case of atrial percutaneous delivery.

In either the case of a full or partial prosthesis, the tethers 4920,6112; 4920, 6172 are attached to each other to secure the respectiveprosthesis in place.

The tethers can be knotted together via using a knot pusher to push oneor more knots along the rails/tethers to a location proximate theprosthesis. Additionally or alternatively, the rails/tethers can besecured to each other by way of clips, crimps, buckles and the like.

As illustrated in FIGS. 63A, 63B, 63C, 63D, 63E, and 64A-64B, the railscan be anchored within the mitral valve leaflets 1002, 1004. Asillustrated in FIG. 63A, mitral leaflets 1002, 1004 are captured by adelivery system 6300. The leaflets are then pierced and an anchor (e.g.,4910) and rail (e.g., 4920) are advanced through the leaflet as depictedin FIG. 63B.

It will be appreciated that a variety of mechanisms can be used tocapture the leaflets. If desired, a suturing device can be used to passa tether/suture through each leaflet. Suitable examples of such suturingdevices can be found, for example, in U.S. Pat. Nos. 7,862,572 and7,993,354. These patents are incorporated by reference herein in theirentireties.

A crimped prosthesis is then advanced over the tethers as illustrated inFIG. 63C, and locked in place as illustrated in FIG. 63D. In FIG. 63E,the tissue prosthesis valve is shown in place, and locked. Afterchecking all the vital signs, the reaming of temporary rails are removedand the procedure is then complete. Once adequate performance of theprosthesis is confirmed, the tethers are cut and installation iscomplete. As with earlier embodiments a prosthesis with integral tetherscan also be used to anchor the tethers to the tethers that are attachedto the leaflets as depicted in FIGS. 64A-64B. In FIG. 64A, shows aleaflets dual active fixation apical approach wherein the first of twoactive fixation rails occurs and the leaflets are attached to thedeployed prosthesis. In the 2^(nd) fixation, the active fixation railsare attached to a second place. Finally, as shown in FIG. 64A, the twoends of the rails are knotted and advanced to lock the prosthesis inplace. In FIG. 64B, the leaflets and annulus dual active fixation andfinal knotting and locking is shown.

In accordance with a further embodiment, and as depicted in FIG. 65, aprosthesis 6500 can be installed above the mitral opening to helpcontrol regurgitation. The prosthesis preferably includes a flexiblegenerally planar body housed, for example, in a structural loop that canoptionally have conduits 6510 for receiving rails, and can be attachedproximate the commissures or elsewhere about the mitral annulus. Theprosthesis can be advanced along the rails as discussed herein tofacilitate alignment and installation. The rails can be placed in anymanner as described herein, including apical or retrograde placement.Preferably, the planar body is made from fabric and/or living tissuethat absorbs the force of blood rushing past a defective native mitralvalve arrangement to reduce or prevent regurgitation. As such, theprosthesis 6500 sits on the atrial side of the mitral valve, and canfill with and block the flow of blood from the ventricle into theatrium. As such, the size of the prosthesis 6500 should be selected toadequately cover any gap between the native leaflets. Preferably,prosthesis 6500 is installed while the heart is beating and withoutmodifying the native leaflets. It is believed that prosthesis 6500 canbe useful in treating various mitral abnormalities, including anenlarged heart, and/or calcification of the existing leaflets, amongother disorders. Preferably, the prosthesis 6500 includes living tissueor can accept ingrowth of existing tissue such that the prosthesis 6500is eventually at least partially composed of a patient's own tissue. Assuch, prosthesis 6500 can be made by growing a patient's cells over aframework outside of the patient and later installed, and/or the growthof tissue can occur inside of the patient after installation. In anotherembodiment, prosthesis 6500 is synthetic only and does not includeliving tissue before or after installation. By way of further example,prosthesis 6500 can later be removed if another procedure is desired,including but not limited to installing a prosthesis similar toprosthesis 6500.

In some embodiments, percutaneous radio frequency mechanical placationcan be performed to burn away a portion or all of the original valveleaflets, if desired, to enhance operation.

In accordance with further embodiments, systems and techniques areprovided for delivering a prosthesis to a target location within apatient's lumenal system using temporary rails.

For purposes of illustration, and not limitation, and as depicted inFIGS. 66A, 66B, 67A, 68A, 68B, 69-73, systems and techniques areprovided showing the use of temporary rails or tethers to help deliver aprosthesis to a target location with in a patient's anatomy by way ofapical access. It is believed that such techniques provide enhancedsecurity and safety, especially in dynamic environments, such as theheart, which are hard to visualize, even with motion compensatingdevices and imaging.

In accordance with the illustrated embodiment, loops that function asrails can be directed over a structural portion of a prosthesis (e.g.,conduit or strut) and delivered to a target location. After theprosthesis is deployed and positioned in place, the rails or loops canbe used to advance secondary devices to the site, such as clip appliersand the like to anchor the prosthesis in place. After advancing anddeploying a secondary device or other devices, the rails/loops can becut and removed from the patient.

As illustrated in FIG. 66A, the number of the rails/loops that areattached to the prosthesis can be as low as one on either side of theprosthesis, and can be practiced with respect to any prosthesisdisclosed herein. Preferably, the loops are preloaded on the prosthesis,which can then be crimped and loaded onto a delivery catheter. Portionsof the fixation system (e.g., anchor or retainer/clip deliverymechanisms) can be preloaded over the rails/loops, such as 2 to 3 cmaway from the prosthesis annulus, as depicted in FIG. 66B.

FIGS. 67A a-b and c-d illustrate two different exemplary configurationsof the fixation system portion of the delivery system. The fixationcatheters have a central lumen that hold an anchor and can include anover the wire or rapid exchange structure for advancing the fixationcatheters along the temporary loop rails. FIG. 68A illustrates exemplaryprostheses and fixation systems for atrial delivery. While it ispreferred that the fixation catheters are preloaded on the loop rails,it is similarly contemplated, as shown in FIG. 68B, to load them overthe loop rails after the prosthesis is deployed.

FIG. 69 depicts a cross-section of an exemplary delivery systemcontaining a crimped prosthesis and fixation catheters disposed overloop rails in a proximal region. The catheter includes a distal regionportion that may include a guidewire port and one or more expandablemembers or balloons that permit perfusion when deployed. The inflatablemember can be used to hold the prosthesis in place with respect to thedelivery system when it is deployed to permit the fixation catheters tobe used to attach the prosthesis to the anatomy.

FIG. 70 illustrates the delivery system being advanced to the mitralvalve by way of the left ventricle over a guidewire. The distal regionof the delivery system is advanced through the mitral orifice and theprosthesis is deployed as illustrated in FIG. 72. Clips or anchors areapplied by way of the fixation catheters. Finally, the temporary loopsare removed from the patient, leaving the installed prosthesis in place.FIG. 71 illustrates a portion of an alternative method using an atrialapproach.

Generally, the prosthesis should be held in place firmly, so thefixation catheters can be advanced to the prosthesis. In an apicalaccess procedure (e.g., FIG. 71), holding and putting light tension inapex direction on the temporary loop rails can prevent the stent frombeing dislodged, while the fixation catheters are being advanced overthe rails to a desired location above the annulus.

The structure of any prosthesis disclosed herein can include resorbablematerial such that the structures can be resorbed over time. Suitablematerials for this purpose can include, for example, one or more of PLA(polylactic acid), PGA (polyglycolic acid), PLA/PGA (copolymers), PCL(polycaprolactone) and the like.

It will be appreciated that the delivery concepts herein using anchoredrails have applicability in other procedures. For example, in analternative embodiment, repair of an abdominal aortic aneurysm can beaccomplished by advancing a prosthesis, such as a stent graft outfittedwith one or more conduits for receiving the rails and, if desired one ormore tethers for being tied to the one or more rails as defined herein.Precise placement of a stent graft can be very important when attemptingto deposit a stent graft in the abdominal aorta as a number of arteriesbranch off from the aorta in this region. Thus, it is advantageous tonot have the stent block these vessels. Anchors can be disposed in thevessel wall to provide the rail system in accordance with thedescription above and the stent graft or other prosthesis can beadvanced to the target location and secured in place at the precisedesired location. Similar techniques using a rail system can be used todeliver stent or stent graft structures with or without integral tethersat any desired location in a patient's anatomy.

While the delivery of a tethered or other stent or stent graft can takeplace in an artery or vein, the disclosed rail system can be used todeliver such prostheses into other lumenal systems in a patient. Inaccordance with one example, the disclosed delivery system can be usedto deliver a stent or stent graft into the pulmonary system (e.g.,bronchial passages) of a patient. The prosthesis can be loaded ontorails that have been previously installed in accordance with theabove-described techniques and then advanced to a precise targetlocation within the patient's lungs and secured in place.

By way of further example, the disclosed delivery system can be used todeliver a stent, stent graft or other prosthesis into thegastrointestinal tract of a patient. The prosthesis can be loaded ontorails that have been previously installed in accordance with theabove-described techniques at a target location in the GI tract and thenadvanced to a precise target location within the patient's lungs andsecured in place. For example, it may be necessary to implant a newstomach valve (synthetic or made of living tissue) in a patient or toinstall a stent or other structure in the bowels of a patient tomaintain patency.

By way of further example, the disclosed delivery system can be used todeliver a stent, stent graft or other prosthesis (synthetic or made ofliving tissue) into the urinary system of a patient. The prosthesis canbe loaded onto rails that have been previously installed in accordancewith the above-described techniques at a target location, such as theurethra in the region of a partially resected prostate, and thenadvanced to a precise target location within the urethra and secured inplace. By way of further example, a flared prosthesis could also beinstalled using premounted rails in the exit of the urinary bladder inorder to maintain patency.

By way of further example, the disclosed delivery system can be used todeliver a stent, stent graft or other prosthesis (synthetic or made ofliving tissue) into the reproductive system of a patient. The prosthesiscan be loaded onto rails that have been previously installed inaccordance with the above-described techniques at a target location,such as the fallopian tube, and then advanced to a precise targetlocation within the fallopian tube and secured in place.

In further accordance with the disclosure, an access port is providedherein having the physical attributes, for example, of the prosthesis ofFIG. 1, but wherein the passage through the prosthesis includes an irisor other valve to permit passage of a surgical instrument therethrough.For example, such an instrument can be advanced and installed in anopening in the stomach wall for accessing the thoracic cavity or can beadvanced and installed through the vagina to access portions of apatient's abdominal cavity.

One of ordinary skill in the art will appreciate that the presentinvention is not limited to the specific exemplary embodiments describedherein. Many alterations and modifications may be made by those havingordinary skill in the art without departing from the spirit and scope ofthe invention. Therefore, it must be expressly understood that theillustrated embodiments have been shown only for the purposes of exampleand should not be taken as limiting the invention, which is defined bythe following claims. These claims are to be read as including what theyset forth literally and also those equivalent elements which areinsubstantially different, even though not identical in other respectsto what is shown and described in the above illustrations.

What is claimed is:
 1. A method for treating a lumenal anatomicallocation, comprising: a) advancing a distal region of a deliverycatheter proximate a target location in a patient's lumenal system; b)dispensing a penetrating member from the delivery catheter proximate thetarget location; c) advancing the penetrating member through a firstportion of lumenal tissue proximate the target location to define afirst passage; d) advancing an end of a first tether through the firstpassage, the first tether having a first anchor disposed at the endthereof; e) advancing the first tether through the first passage untilthe first anchor bears against tissue proximate the first passage; f)disposing a prosthesis over the first tether; and g) advancing theprosthesis over the first tether to a position proximate the targetlocation.
 2. The method of claim 1, wherein the method furthercomprises: a) advancing the penetrating member through a second portionof lumenal tissue proximate the target location to define a secondpassage; b) advancing an end of a second tether through the secondpassage, the second tether having a second anchor disposed at the endthereof; c) advancing the second tether through the second passage untilthe second anchor bears against tissue proximate the second passage; d)disposing a prosthesis over the first and second tethers; and e)advancing the prosthesis over the first and second tethers to a positionproximate the target location.
 3. The method of claim 1, furthercomprising anchoring the prosthesis in place in the target locationusing at least one retainer.
 4. The method of claim 3, wherein theretainer is attached to the first tether and urges the prosthesis andanchor toward one another along the first tether.
 5. The method of claim1, wherein the prosthesis defines an open lumen upon installation. 6.The method of claim 5, further comprising disposing a second prosthesiswithin the open lumen.
 7. The method of claim 6, wherein the secondprosthesis includes a lumenal valve.
 8. The method of claim 7, whereinthe lumenal valve includes synthetic material.
 9. The method of claim 7,wherein the lumenal valve includes living tissue.
 10. The method ofclaim 2, wherein the target location is proximate a patient's mitralannulus.
 11. The method of claim 10, wherein the first and secondpassages pass through the commissures of the mitral valve.
 12. Themethod of claim 1, wherein the prosthesis includes at least one tetherattached thereto, and the method further includes attaching theprosthesis tether to the first tether to secure the prosthesis in place.13. The method of claim 1, wherein the delivery catheter enters theheart through an incision proximate the bottom of the left ventricle.14. The method of claim 1, wherein the delivery catheter enters theheart through an incision proximate the top of the left atrium.
 15. Themethod of claim 1, wherein the delivery catheter enters the heartpercutaneously via an artery.
 16. A method for treating a lumenalanatomical location, comprising: a) advancing a distal region of adelivery catheter proximate a target location in a patient's lumenalsystem; b) deploying a prosthesis from a distal region of the catheter,the prosthesis having at least one tether connected thereto forcontrolling placement of the prosthesis.
 17. The method of claim 16,further comprising inflating an inflatable member inside the prosthesisto hold the prosthesis in place while the fixation catheter is used tosecure the prosthesis to the tissue of the patient.
 18. The method ofclaim 16, further comprising: a) directing a fixation catheter over thetether to the prosthesis; and b) applying at least one retainer tosecure the prosthesis.